NEPHRON PRODUCT CATALOG 2025

2025

PRODUCT CATALOG

Nephron Pharmaceuticals Corporation is a certified woman-owned business with over 27 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 Sulfate Inhalation Solution, 0.021% Singles - 30 Count

0487-0301-01

Albuterol Sulfate Inhalation Solution, 0.042% Singles - 25 Count

0487-9904-25

Albuterol Sulfate Inhalation Solution, 0.042% Singles - 30 Count

0487-9904-01

Albuterol Sulfate Inhalation Solution, 0.083% Singles - 30 Count

0487-9501-01

Albuterol Sulfate 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

IC # 547 Rev. 10-04-17

503B PRODUCTS PRODUCT DESCRIPTION

NDC

Albuterol Sulfate 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

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, 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

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 90 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

ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%

25 mg/5 mL (5 mg/mL) - Preservative Free

NDC CODE 69374-330-05

mL PER UNIT 5

BUD 270 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

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.

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.

VIEW WEBSITE

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

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.

VIEW WEBSITE

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

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