NEPHRON PRODUCT CATALOG 2025

2025

PRODUCT CATALOG

Nephron Pharmaceuticals is a certified woman-owned business with over 28 years of experience manufacturing safe, affordable generic inhalation solutions and suspension products. The award-winning, 840,000 square-foot facility in West Columbia, SC also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. Nephron was designed to lead the world in blow-fill-seal (BFS) manufacturing. This technology forms, fills, and seals vials in one continuous process without human intervention. With BFS technology, Nephron is able to produce one billion doses of medication each year.

To learn more about Nephron, visit nephronpharm.com .

RESPIRATORY DIRECT INHALATION PRODUCTS (ANDA)

NDC

Albuterol Inhalation Solution, 0.021% Singles - 30 Count

0487-0301-01

Albuterol Inhalation Solution, 0.042% Singles - 30 Count

0487-9904-01

Albuterol Inhalation Solution, 0.083% Singles - 30 Count

0487-9501-01

Albuterol Inhalation Solution, 0.5% Singles - 30 Count

0487-9901-30

Budesonide Inhalation Suspension, 0.25 mg/ 2 mL Inhalation Singles - 30 Count

0487-9601-01

Budesonide Inhalation Suspension, 0.5 mg/ 2 mL Inhalation Singles - 30 Count

0487-9701-01

Ipratropium Bromide Inhalation Solution, 0.02% Singles - 30 Count

0487-9801-01

Ipratropium Bromide 0.5 mg & Albuterol Sulfate 3 mg Inhalation Solution - 30 Count

0487-0201-01

S-2 Racepinephrine Inhalation Solution, USP, 2.25% Singles - 30 Count

0487-5901-99

Sodium Chloride Inhalation Solution, USP, 0.9% Singles - 30 Count

0487-9301-33

REF

Sodium Chloride Inhalation Solution, USP, 3% Singles - Individual Unit Dose

0487-9003-30

REF

Sodium Chloride Inhalation Solution, USP, 7% Singles - Individual Unit Dose

0487-9007-30

REF

Pocket Neb™ Portable Vibrating Mesh Nebulizerx

PNVM-510K-01

NDC 0487-9901-30

NDC 0487-9904-01

NDC 0487-0301-01

Read this patient information completely every time your prescription is filled as information may have changed. Contact your physician and pharmacist if you have additional questions. Do not use after the expiration date printed on the vial. 1. Remove the vial from the foil pouch. 2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir. 3. Connect the nebulizer to the mouthpiece or face mask. 4. Connect the nebulizer to the compressor. 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth or put on the face mask; and turn on the compressor. deeply, and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. 6. Breathe as calmly, 7. Clean the nebulizer (see manufacturer’s instructions). Patient’s Instructions For Use LOT/EXP:

Read this patient information completely every time your prescription is filled as information may have changed. Contact your physician and pharmacist if you have additional questions. Do not use after the expiration date printed on the vial. 1. Remove the vial from the foil pouch. 2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir. 3. Connect the nebulizer to the mouthpiece or face mask. 4. Connect the nebulizer to the compressor. 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth or put on the face mask; and turn on the compressor. 6. Breathe as calmly, deeply, and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. 7. Clean the nebulizer (see manufacturer’s instructions). Patient’s Instructions For Use

1. Twist open the top of one albuterol inhalation solution unit-of-use container. 2. Squeeze the solution into the nebulizer reservoir through the appropriate opening. 3. Add 2.5 mL of sterile normal saline solution, as your doctor has directed. 4. Gently swirl the nebulizer to mix the contents and connect it with the mouthpiece or face mask. 5. Connect the nebulizer to the compressor. LOT/EXP: 6. Sit in a comfortable upright position; place the mouthpiece in your mouth (or put on the face mask); and turn on the compressor. 7. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. 8. Clean the nebulizer (see manufacturer’s instructions). Read complete instructions carefully before using. Patient’s Instructions For Use

NDC 0487-9501-01

Read complete instructions carefully before using. 1. Twist open the top of one albuterol inhalation solution unit-dose vial and squeeze the contents into the nebulizer reservoir. 2. Connect the nebulizer reservoir to the mouthpiece or face mask. 3. Connect the nebulizer to the compressor. 4. Sit in a comfortable, Patient’s Instructions For Use upright position; place the mouthpiece in your mouth or put on the face mask; and turn on the compressor. deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. 5. Breathe as calmly, 6. Clean the nebulizer (see manufacturer’s instructions).

2.5 mg* / 0.5 mL *Potency expressed as albuterol. Albuterol Inhalation Solution, USP 0.5%* FOR ORAL INHALATION ONLY DILUTE BEFORE USE

1.25 mg* / 3 mL *Potency expressed as albuterol. Albuterol Inhalation Solution, USP 0.042%* SEE BACK OF POUCH FOR PATIENT’S INSTRUCTIONS EACH 3 ML VIAL CONTAINS : Active : Albuterol Sulfate USP (1.25 mg as albuterol) Inactives : Sodium chloride, sulfuric acid (to adjust pH between 3 and 5) and water for injection. STORAGE CONDITIONS: PROTECT FROM LIGHT. Store between 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store the unit-dose vial in the protective foil pouch at all times. Once removed from the foil pouch, use the vial within one week. Discard the vial if the solution is not colorless. Keep out of reach of children. USUAL DOSAGE: For use in children ages 2-12, see accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE. FOR ORAL INHALATION ONLY

0.63 mg* / 3 mL *Potency expressed as albuterol. Albuterol Inhalation Solution, USP 0.021%* FOR ORAL INHALATION ONLY SEE BACK OF POUCH FOR PATIENT’S INSTRUCTIONS EACH 3 ML VIAL CONTAINS : Active : Albuterol Sulfate USP (0.63 mg as albuterol) Inactives : Sodium chloride, sulfuric acid (to adjust pH between 3 and 5) and water for injection. STORAGE CONDITIONS: PROTECT FROM LIGHT. Store between 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store the unit-dose vial in the protective foil pouch at all times. Once removed from the foil pouch, use the vial within one week. Discard the vial if the solution is not colorless. Keep out of reach of children. USUAL DOSAGE: For use in children ages 2-12, see accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE.

2.5 mg* / 3 mL *Potency expressed as albuterol. Albuterol Inhalation Solution, USP 0.083%* SEE BACK OF POUCH FOR PATIENT’S INSTRUCTIONS Equivalent to 0.5 mL albuterol sulfate 0.5%* diluted to 3 mL with normal saline. Each mL contains albuterol sulfate USP equivalent to 0.83 mg albuterol in an aqueous solution containing sodium chloride and sulfuric acid to adjust pH between 3 and 5. Contains no preservatives. Please consult your physician before use. Do not exceed recommended dosage. USUAL DOSAGE : See package insert. STORAGE CONDITIONS: Protect from light. Store between 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store in pouch until time of use. Discard if solution becomes discolored. (Note: Albuterol inhalation solution, USP is a clear, colorless to light yellow solution.) FOR ORAL INHALATION ONLY

SEE BACK OF POUCH FOR PATIENT’S INSTRUCTIONS

Each 0.5 mL unit-of-use vial contains 2.5 mg albuterol (equivalent to 3 mg albuterol sulfate) in an aqueous solution; sulfuric acid is used to adjust pH between 3 and 5. Contains no preservatives. Please consult your physician before use. Do not exceed recommended dosage. Protect from light. Store between 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Discard if solution becomes discolored. (Note: Albuterol inhalation solution, USP is a clear, colorless to light yellow solution.)

LOT/EXP:

Manufactured By:

Please consult your doctor before use. Do not exceed recommended dose.

West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 IC 2976 Rev 01-10-25

West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313

West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 IC 2969 Rev 01-10-25

West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 IC 2967 Rev 01-10-25

STERILE One 3 mL Unit-Dose Vial

STERILE One 0.5 mL Unit-of-Use Vial

STERILE One 3 mL Unit-Dose Vial

IC 2974 Rev 10-25-24

110 mm (4.3307”) Cut Web Width

IC # 547 Rev. 10-04-17

503B PRODUCTS PRODUCT DESCRIPTION

NDC

Albuterol Inhalation Solution, 0.5% 25 mg/5 mL (5 mg/mL) - PF

69374-330-05

Amino Acid Injection, 50 g/1000 mL (50 mg/mL)

69374-988-10

del Nido Cardioplegia Solution, 1000 mL (1000 mL)

69374-984-10

Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 250 mL (10 mcg/mL) - PF

69374-323-25

Ketamine HCI Injection, USP, 50 mg/ 5 mL (10 mg/mL)

69374-308-05

Labetalol HCl Injection Vial, USP, 20 mg/4 mL (5 mg/mL) - PF

69374-946-34

Neostigmine Methylsulfate Injection Vial, USP 5 mg/5 mL (1 mg/mL) - PF

69374-902-35

0.2% Ropivacaine HCI Injection, USP, 1 g/500 mL (2 mg/mL) - PF

69374-987-50

0.9% Sodium Chloride Injection, USP, 500 mL

69374-334-50

PARTNER PRODUCTS PRODUCT DESCRIPTION

NDC

Bupivacaine HCI Ampule, 0.5% 10 mL - Areva Pharmaceuticals

59923-720-10

Caspofungin Acetate For Injection, 50 mg/10 mL - Areva Pharmaceuticals

59923-614-50

Caspofungin Acetate For Injection, 70 mg/10 mL - Areva Pharmaceuticals

59923-613-70

Fludarabine Phosphate Injection, 50 mg/2 mL - Areva Pharmaceuticals

59923-604-02

Temozolomide Capsules, 100 mg - Areva Pharmaceuticals

59923-708-14

Temozolomide Capsules, 140 mg - Areva Pharmaceuticals

59923-710-14

Terbutaline Sulfate Injection, 1 mg/ 1 mL - Areva Pharmaceuticals

59923-615-05

NDC: 69374-984-10

Each 100 mL contains: L-lysine HCl, USP 2.5 g (equivalent to 2 g lysine); L-arginine HCl, USP 2.5 g (equivalent to 2.07 g arginine); Sodium Chloride, USP 900 mg; in Water for Injection, USP q.s.; Osmolarity: 730-880 mOsmol/L 25 g L-Arginine HCl; 25 g L-Lysine HCl Amino Acid Injection NDC: 69374-988-10 50 g/1000 mL (50 mg/mL) Additives may be incompatible with fluids withdrawn from this container. Consult with pharmacist if available when compounding admixtures, use aseptic technique, mix thoroughly. Contains no more than 25 µg/L of aluminum. Dosage: Admix for intravenous administration as directed by a physician. Once the container has been opened, the contents should be used immediately. Caution: Do not use unless solution is clear. Store at 20°C-25°C (68°F-77°F) [See USP Controlled Room Temperature]. This is a Compounded Drug. Hospital/Office Use Only. Discard Unused Portion. Not for Resale. Single-Dose Container.

1000 mL del Nido Cardioplegia Solution For Cardiac Perfusion Electrolyte Concentration : Sodium 145 mmol/L; Chloride 121 mmol/L; Potassium 29 mmol/L; Magnesium 9 mmol/L WARNING: NOT FOR INTRAVENOUS INJECTION Each 100 mL contains : Sodium Chloride, USP 499.6 mg; Sodium Gluconate, USP 476.8 mg; Sodium Acetate Trihydrate, USP 349.5 mg; Potassium Chloride, USP 219.3 mg; Magnesium Chloride Hexahydrate, USP 28.5 mg; Mannitol, USP 309.7 mg; Sodium Bicarbonate, USP 103.7 mg; Magnesium Sulfate Anhydrous, USP 92.8 mg;

Lidocaine HCl, USP 12.3 mg; in Water for Injection, USP q.s.

Single-Dose Container. Discard Unused Portion. Hospital/Office Use Only. Not for Resale.

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088

This is a Compounded Drug. Storage Conditions: 2°C-8°C Protect from Freezing.

4500 12th St. Extension West Columbia, SC 29172 1-844-224-2225 CIC2472 Rev 02-12-24

Data matrix For Internal Purposes Only

LOT: PPY000S EXP: 00/00/0000 COMP: 00/00/0000

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088

(17)210000(10)PPY000S

(17)210000(10)PPY000S 4500 12th St. Extension West Columbia, SC 29172 1-844-224-2225 CIC2382 Rev 12-03-20

Data matrix For Internal Purposes Only

(01)00369374988100

LOT: PPY000S EXP: 00/00/0000 COMP: 00/00/0000

(01)00369374984102

Each 100 mL contains: Sodium Chloride USP 900 mg in Water for Injection, USP; pH 5.6 (4.5 to 7.0); Sodium 154 mEq/L; Chloride 154 mEq/L; pH adjusters: HCl/NaOH; Osmolarity 308 mOsmol/L (calc). For Intravenous Use This is a Compounded Drug. Do not use unless solution is clear. Discard Unused Portion. Hospital/Office Use Only. Not for Resale. Store unit at Room Temperature 20° - 25°C (68° - 77°F) until ready for use. Avoid excessive heat. 500 mL Single-Dose I.V. Bottle STERILE NONPYROGENIC 0.9% Sodium Chloride Injection, USP NDC: 69374-334-50

For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Use. Each 100 mL contains : Ropivacaine HCl, USP 200 mg; Sodium Chloride, USP 860 mg; in Water for Injection, USP q.s.; pH adjusters: HCl/NaOH; pH 4.0 to 6.0. Preservative Free. This is a Compounded Drug. Not for Resale. Hospital/Office Use Only. Store at 20°C-25°C (68°F-77°F). Single-Dose Container. Discard Unused Portion. 0.2% Ropivacaine HCl Injection, USP 1 g/500 mL (2 mg/mL) NDC: 69374-987-50

Data matrix For Internal Purposes Only

4500 12th St. Extension West Columbia, SC 29172 1-800-443-4313

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088

LOT: PPY000S EXP: 0000-00-00 COMP: 0000-00-00

(17)250000(10)PPY000S

CIC2672 Rev 04-30-24

(01)00369374987509

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088 CIC3646 Rev 11-08-24

4500 12th St. Extension West Columbia, SC 29172 1-800-443-4313

Scan to read IV Bottle Instructions for Use:

LOT: EXP: COMP:

PPY000S 0000-00-00 0000-00-00

(17)250000(10)PPY000S

(01)00369374334501

AMINO ACID INJECTION 50 G/1000 ML (50 MG/ML)

50 g/1000 mL (50 mg/mL)

NDC CODE 69374-988-10

Each 100 mL contains: L-lysine HCl, USP 2.5 g (equivalent to 2 g lysine); L-arginine HCl, USP 2.5 g (equivalent to 2.07 g arginine); Sodium Chloride, USP 900 mg; in Water for Injection, USP q.s.; Osmolarity: 730-880 mOsmol/L 25 g L-Arginine HCl; 25 g L-Lysine HCl Amino Acid Injection NDC: 69374-988-10 50 g/1000 mL (50 mg/mL) Additives may be incompatible with fluids withdrawn from this container. Consult with pharmacist if available when compounding admixtures, use aseptic technique, mix thoroughly. Contains no more than 25 µg/L of aluminum. Dosage: Admix for intravenous administration as directed by a physician. Once the container has been opened, the contents should be used immediately. Caution: Do not use unless solution is clear. Store at 20°C-25°C (68°F-77°F) [See USP Controlled Room Temperature] . This is a Compounded Drug. Hospital/Office Use Only. Discard Unused Portion. Not for Resale. Single-Dose Container.

mL PER UNIT 1000

BUD 120 Days

(*from formulation)

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088

STORAGE CONDITION Room Temperature

4500 12th St. Extension West Columbia, SC 29172 1-844-224-2225 CIC2472 Rev 02-12-24

Data matrix For Internal Purposes Only

LOT: PPY000S EXP: 00/00/0000 COMP: 00/00/0000

(17)210000(10)PPY000S

(01)00369374988100

PRODUCT TYPE IV Bag

CARTONS PER CASE 2 UNITS PER CARTON 1 TOTAL UNITS PER CASE 2

25 mg/5 mL (5 mg/mL) - Preservative Free ALBUTEROL INHALATION SOLUTION, 0.5%

NDC CODE 69374-330-05

mL PER UNIT 5

BUD 365 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Plastic Vial

CARTONS PER CASE 30 UNITS PER CARTON 30 TOTAL UNITS PER CASE 900

Product is available by the carton.

VIEW WEBSITE

DEL NIDO CARDIOPLEGIA SOLUTION

1000 mL

NDC: 69374-984-10

NDC CODE 69374-984-10

mL PER UNIT 1000

Lidocaine HCl, USP 12.3 mg; in Water for Injection, USP q.s.

Single-Dose Container. Discard Unused Portion. Hospital/Office Use Only. Not for Resale.

This is a Compounded Drug. Storage Conditions: 2 °C-8°C Protect from Freezing.

BUD 90 Days

(*from formulation)

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088

(17)210000(10)PPY000S 4500 12th St. Extension West Columbia, SC 29172 1-844-224-2225 CIC2382 Rev 12-03-20

Data matrix For Internal Purposes Only

LOT: PPY000S EXP: 00/00/0000 COMP: 00/00/0000

(01)00369374984102

STORAGE CONDITION Refrigerated

PRODUCT TYPE IV Bag

CARTONS PER CASE 4 UNITS PER CARTON 1 TOTAL UNITS PER CASE 4

FENTANYL CITRATE IN 0.9% SODIUM CHLORIDE INJECTION, USP

2500 mcg/250 mL (10 mcg/mL)

NDC CODE 69374-323-25

mL PER UNIT 250

BUD 90 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Premium IV Bag

CARTONS PER CASE 15 UNITS PER CARTON 1 TOTAL UNITS PER CASE 15

VIEW WEBSITE

KETAMINE HCI INJECTION VIAL, USP

50 mg/5 mL (10 mg/mL)

NDC CODE 69374-308-05

mL PER UNIT 5

BUD 270 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Luer-Lock Plastic Vial

CARTONS PER CASE 30 UNITS PER CARTON 30 TOTAL UNITS PER CASE 900

Product is available by the carton.

20 mg/4 mL (5 mg/mL) - Preservative Free LABETALOL HCI INJECTION VIAL, USP

NDC CODE 69374-946-34

mL PER UNIT 4

BUD 365 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Luer-Lock Plastic Vial

CARTONS PER CASE 30 UNITS PER CARTON 30 TOTAL UNITS PER CASE 900

Product is available by the carton.

VIEW WEBSITE

NEOSTIGMINE METHYLSULFATE INJECTION VIAL, USP 5 mg/5 mL (1 mg/mL) - Preservative Free

NDC CODE 69374-902-35

mL PER UNIT 5

BUD 365 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Luer-Lock Plastic Vial

CARTONS PER CASE 30 UNITS PER CARTON 30 TOTAL UNITS PER CASE 900

Product is available by the carton.

0.2% ROPIVACAINE HCI INJECTION, USP

1 g/500 mL (2 mg/mL) - Preservative Free

NDC CODE 69374-987-50

mL PER UNIT 500

BUD 180 Days

(*from formulation)

Data matrix For Internal Purposes Only

4500 12th St. Extension West Columbia, SC 29172 1-800-443-4313

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088

LOT: PPY000S EXP: 0000-00-00 COMP: 0000-00-00

(17)250000(10)PPY000S

STORAGE CONDITION Room Temperature

CIC2672 Rev 04-30-24

(01)00369374987509

PRODUCT TYPE IV Bag

CARTONS PER CASE 10 UNITS PER CARTON 1

TOTAL UNITS PER CASE

VIEW WEBSITE

0.9% SODIUM CHLORIDE INJECTION, USP 500 mL

NDC CODE 69374-334-50

mL PER UNIT 500

BUD 90 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Premium IV Bag

Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088 CIC3646 Rev 11-08-24

4500 12th St. Extension West Columbia, SC 29172 1-800-443-4313

Scan to read IV Bottle Instructions for Use:

LOT: EXP: COMP:

PPY000S 0000-00-00 0000-00-00

(17)250000(10)PPY000S

CARTONS PER CASE 10 UNITS PER CARTON 1 TOTAL UNITS PER CASE 10

(01)00369374334501

Product is available by the carton.

OUR MISSION IS BETTER HEALTH CARE OUTCOMES.

VIEW WEBSITE

PRODUCT MANUFACTURED BY AREVA PHARMACEUTICALS All orders placed for this product will be shipped directly from Areva Pharmaceuticals.

Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50