NEPHRON PRODUCT CATALOG 2024

2024

PRODUCT CATALOG

Nephron Pharmaceuticals Corporation is a certified woman-owned business with over 26 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

NDC

PRODUCT DESCRIPTION

Albuterol Sulfate Inhalation Solution, 0.5% 25 mg/5 mL (5 mg/mL) - Preservative Free

69374-330-05

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

69374-988-10

Conivaptan HCI Injection, Premixed in 5% Dextrose 20 mg/100 mL (0.2 mg/mL)

69374-564-10

del Nido Cardioplegia Solution, 1000 mL (1000 mL)

69374-984-10

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

69374-982-55

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

69374-946-34

Lidocaine HCl Injection Vial, USP, 1% 50 mg/5 mL (10 mg/mL) - Preservative Free

69374-520-05

PRODUCED BY MARKET DEMAND

Lidocaine HCl Injection Vial, USP, 2% 100 mg/5 mL (20 mg/mL) - Preservative Free

69374-949-35

PRODUCED BY MARKET DEMAND

Neostigmine Methylsulfate Injection Vial, USP 5 mg/5 mL (1 mg/mL) Preservative Free 69374-902-35

Phenylephrine HCI Injection, USP, 1 mg/10 mL (100 mcg/mL)

69374-957-10

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) - Preservative Free 69374-919-10

PARTNER PRODUCTS

NDC

PRODUCT DESCRIPTION

Bupivacaine HCI Ampule, 0.5% 10 mL - Areva Pharmaceuticals

59923-720-10

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

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;

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.

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.

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

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

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

Data matrix For Internal Purposes Only

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

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

(17)210000(10)PPY000S

Data matrix For Internal Purposes Only

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

(01)00369374988100

(01)00369374984102

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

50 g/1000 mL (50 mg/mL)

NDC CODE 69374-988-10

mL PER UNIT 1000

BUD 180 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE IV Bag

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

LABEL

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 150 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.

LABEL

20 mg/100 mL (0.2 mg/mL) CONIVAPTAN HCI INJECTION, PREMIXED IN 5% DEXTROSE

NDC CODE 69374-564-10

mL PER UNIT 100

BUD 365 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE IV Bag

UNITS PER CARTON 1

LABEL

DEL NIDO CARDIOPLEGIA SOLUTION%

1000 mL

NDC CODE 69374-984-10

NDC: 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

LABEL

KETAMINE HYDROCHLORIDE INJECTION, USP

50 mg/5 mL (10 mg/mL)

NDC CODE 69374-982-55

mL PER UNIT 5

BUD 180 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Pre-Filled Syringe

CARTONS PER CASE 6 UNITS PER CARTON 5 TOTAL UNITS PER CASE 30

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LABEL

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.

LABEL

50 mg/5 mL (10 mg/mL) - Preservative Free LIDOCAINE HCI INJECTION VIAL, USP 1%

NDC CODE 69374-520-05

mL PER UNIT 5

BUD 180 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 and produced by market demand.

LABEL

LIDOCAINE HCI INJECTION VIAL, USP 2% 100 mg/5 mL (20 mg/mL) - Preservative Free

NDC CODE 69374-949-35

mL PER UNIT 5

BUD 180 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 and produced by market demand.

LABEL

NEOSTIGMINE METHYLSULFATE INJECTION VIAL, USP

5 mg/5 mL (1 mg/mL) - Preservative Free

NDC CODE 69374-902-35

mL PER UNIT 5

BUD 180 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.

LABEL

PHENYLEPHRINE HCL INJECTION, USP

1 mg/10 mL (100 mcg/mL)

NDC CODE 69374-957-10

mL PER UNIT 10

BUD 180 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Pre-Filled Syringe

CARTONS PER CASE 6 UNITS PER CARTON 5 TOTAL UNITS PER CASE 30

LABEL

SUCCINYLCHOLINE CHLORIDE INJECTION, USP

200 mg/10 mL (20 mg/mL) - Preservative Free

NDC CODE 69374-919-10

mL PER UNIT 10

BUD 90 Days

(*from formulation)

STORAGE CONDITION Room Temperature

PRODUCT TYPE Pre-Filled Syringe

CARTONS PER CASE 6 UNITS PER CARTON 5 TOTAL UNITS PER CASE 30

LABEL

US ABOUT NG!

PRODUCT MANUFACTURED BY AREVA PHARMACEUTICALS

2024 NEPHRON RESPIRATORY DIRE NDC PRODUCT DESCRIPTION (single individually wrapped and barcoded) 0487-0301-01 Albuterol Sulfate Inhalation Solution, 0.021% 0487-9904-25 Albuterol Sulfate Inhalation Solution, 0.042% 0487-9904-01 Albuterol Sulfate Inhalation Solution, 0.042% 0487-9501-01 Albuterol Sulfate Inhalation Solution, 0.083% 0487-9901-30 Albuterol Sulfate Inhalation Solution, 0.5% 0487-9601-01 Budesonide Inhalation Suspension 0.25 mg/2 mL 0487-9701-01 Budesonide Inhalation Suspension 0.5 mg/2 mL 0487-9801-01 Ipratropium Bromide Inhalation Solution, 0.02% 0487-0201-01 Ipratropium Bromide 0.5 mg & Albuterol Sulfate 3 mg Inhalation Solution 0487-5901-99 S-2 Racepinephrine Inhalation Solution, USP 2.25% 0487-9301-33 Sodium Chloride Inhalation Solution, USP 0.9% 0487-9003-30 Sodium Chloride Inhalation Solution, USP 3% (individual unit dose) 0487-9007-30 Sodium Chloride Inhalation Solution, USP 7% (individual unit dose) REF REF REF

ECT

VIALS/CARTON

CARTONS/CASE

VIALS/CASE

360

300

360

900

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