Sodium Phenylacetate and Sodium Benzoate (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sodium Phenylacetate and Sodium Benzoate Injection, 10% per 10% is supplied in a sterile, non-pyrogenic, single-dose glass vial.

NDC 72266-247-01
single-dose vial containing 50 mL of
sodium phenylacetate and sodium benzoate injection, 10% per 10%

Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

17 PATIENT COUNSELING INFORMATION

Physicians should advise patients and caregivers about the following for safe use of sodium phenylacetate and sodium benzoate injection:

• When plasma ammonia levels have normalized, dietary protein intake can usually be increased with the goal of unrestricted protein intake.
• The most common adverse reactions are vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.
• Generally BUPHENYL is stopped during the time sodium phenylacetate and sodium benzoate injection is used.

Distributed by:
Fosun Pharma USA Inc.
Princeton, NJ 08540
Made in India

Revised: Aug 2022

PRINCIPAL DISPLAY PANEL – 10%/10%

NDC 72266-247-01 50 mL

Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10%

For IV Use Only

Warning: Administration must be through a central venous catheter.
Administration through a peripheral line may cause burns.

Must be diluted before IV administration

Sterile, non-pyrogenic

Carton Label:

Vial Label:

Rx only Single-Dose Vial

Dosage: See accompanying package insert.

Each mL contains: 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sterile, concentrated solution must be diluted with sterile dextrose injection, 10% (D10W) before intravenous administration.

Discard unused portion.

Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Keep out of reach of children.

SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium phenylacetate and sodium benzoate injection, solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72266-247 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHENYLACETATE (PHENYLACETIC ACID) SODIUM PHENYLACETATE 100 mg in 1 mL SODIUM BENZOATE (BENZOIC ACID) SODIUM BENZOATE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72266-247-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 50 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72266-247-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208521 08/18/2022

Labeler — FOSUN PHARMA USA INC (080920998)

Revised: 05/2023 FOSUN PHARMA USA INC