2024
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
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) - PF
69374-946-34
Neostigmine Methylsulfate Injection Vial, USP 5 mg/5 mL (1 mg/mL) - PF
69374-902-35
Phenylephrine HCI Injection, USP, 1 mg/10 mL (100 mcg/mL)
69374-957-10
Rocuronium Bromide Injection, 50 mg/5 mL (10 mcg/mL) - PF
69374-924-05
0.2% Ropivacaine HCI Injection, USP, 1 g/500 mL (2 mg/mL) - PF
69374-987-50
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) - PF
69374-919-10
PARTNER PRODUCTS PRODUCT DESCRIPTION
NDC
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
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.
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;
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
Data matrix For Internal Purposes Only
LOT: PPY000S EXP: 00/00/0000 COMP: 00/00/0000
(17)210000(10)PPY000S
(01)00369374988100
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
(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
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
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
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;
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 IV Bottle
CARTONS PER CASE 15 UNITS PER CARTON 1 TOTAL UNITS PER CASE 15
VIEW WEBSITE
KETAMINE HYDROCHLORIDE INJECTION, USP
50 mg/5 mL (10 mg/mL)
NDC CODE 69374-982-55
mL PER UNIT 5
BUD 240 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
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.
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
VIEW WEBSITE
50 mg/5 mL (10 mg/mL) - Preservative Free ROCURONIUM BROMIDE INJECTION, USP
NDC CODE 69374-924-05
mL PER UNIT 5
BUD 120 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
0.2% ROPIVACAINE HCI INJECTION, USP
1 g/500 mL (2 mg/mL) - Preservative Free
NDC CODE 69374-987-50
mL PER UNIT 500
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
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 10
VIEW WEBSITE
SUCCINYLCHOLINE CHLORIDE INJECTION, USP
200 mg/10 mL (20 mg/mL) - Preservative Free
NDC CODE 69374-919-10
mL PER UNIT 10
BUD 105 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
OUR MISSION IS BETTER HEALTH CARE OUTCOMES.
VIEW WEBSITE
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
30
12
360
25
12
300
30
12
360
30
12
360
30
12
360
30
12
360
30
12
360
30
12
360
n
30
12
360
30
12
360
30
12
360
30
30
900
30
30
900
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