Sodium Nitroprusside (Page 4 of 4)

HOW SUPPLIED

Sodium Nitroprusside Injection is supplied in amber-colored, 50 mg/2 mL Single Dose Vials (NDC 70436-028-80).

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.

Manufactured by:

Hainan Poly Pharm Co., Ltd.,

Guilinyang Economic Development Area,

Haikou, Hainan Province, China 571127

Distributed by: Slate Run Pharmaceuticals, LLC,

Columbus, Ohio 43215

10000062/01

Revised: 08/2020

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx only

NDC 70436-028-80

Sodium Nitroprusside Injection

50 mg/2 mL

(25 mg/mL)

For Intravenous Infusion only

Must be diluted.

Potent drug: Monitor blood

pressure before and during

administration.

2 mL Single Dose Vial

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SODIUM NITROPRUSSIDE
sodium nitroprusside injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-028
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
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-028-80 1 VIAL in 1 CARTON contains a VIAL
1 2 mL in 1 VIAL This package is contained within the CARTON (70436-028-80)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214199 10/15/2020
Labeler — Slate Run Pharmaceuticals, LLC (039452765)

Revised: 10/2020 Slate Run Pharmaceuticals, LLC

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