Sodium Nitroprusside (Page 4 of 4)

HOW SUPPLIED

Sodium nitroprusside injection is supplied in amber-colored, single-dose 50 mg/2 mL Fliptop Vials (NDC 71839-120-01).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

To protect Sodium nitroprusside injection from light, it should be stored in its carton until it is used.

Distributed by:
BE Pharmaceuticals Inc.
203 New Edition Court
Cary, NC 27511

Manufactured by:

Biological E. Limited
Plot No. 4, Survey no. 542/P, Biotech Park Phase-II,
Kolthur Village, Shameerpet Mandal, Medchal, Telangana 500078, India.

Revised: July 2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Nitroprusside Injection 50mg/2mL (25mg/mL) — Vial Label

Sodium Nitroprusside Injection 50mg/2mL (25mg/mL) — Carton Label

Sodium Nitroprusside Injection 50mg/2mL (25mg/mL) — Sleeve Box Label

Sodium Nitroprusside Injection 50mg/2mL (25mg/mL) — Light Protective Sleeve Label

SODIUM NITROPRUSSIDE sodium nitroprusside injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71839-120 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Nitroprusside (Nitroprusside) Sodium Nitroprusside 50 mg in 2 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71839-120-01 1 VIAL in 1 CARTON contains a VIAL 1 2 mL in 1 VIAL This package is contained within the CARTON (71839-120-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214971 07/12/2021

Labeler — BE Pharmaceuticals Inc. (081499296)

Establishment
Name	Address	ID/FEI	Operations
Biological E. Limited		871410645	ANALYSIS (71839-120), MANUFACTURE (71839-120)

Revised: 07/2021 BE Pharmaceuticals Inc.