NOREPINEPHRINE BITARTRATE injection, solution, concentrate

Norepinephrine Bitartrate by

Drug Labeling and Warnings

Norepinephrine Bitartrate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1724-6

Norepinephrine Bitartrate Injection, USP

4 mg/4 mL (1 mg/mL)

FOR INTRAVENOUS INFUSION ONLY.

STERILE INJECTION

Warning: This is potent drug. Dosage should be controlled by frequent determination of blood pressure.

Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully.

DILUTE BEFORE USE. DISCARD UNUSED PORTION. PROTECT FROM LIGHT.

Warning: Contains Sulfites.

10 X 4 mL Single-Dose Vials

Rx only

NDC: 70771-1724-1

Norepinephrine Bitartrate Injection, USP

4 mg/4 mL (1 mg/mL)

FOR INTRAVENOUS INFUSION ONLY

Warning: Contains Sulfites.

DISCARD UNUSED PORTION.

4 mL Single-Dose Vial

Rx only

INGREDIENTS AND APPEARANCE

NOREPINEPHRINE BITARTRATE 
norepinephrine bitartrate injection, solution, concentrate

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1724
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV)	NOREPINEPHRINE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1724-6	10 in 1 CARTON	04/24/2024
1	NDC: 70771-1724-1	4 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216341	04/24/2024

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1724) , ANALYSIS(70771-1724)