NOREPINEPHRINE BITARTRATE - norepinephrine bitartrate injection, solution, concentrate 
Zydus Lifesciences Limited

----------

NOREPINEPHRINE BITARTRATE injection, for intravenous use

Double click here to open Word Application.

Write ordered list in to word document.

Close Word Application.

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

carton label

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

vial label
NOREPINEPHRINE BITARTRATE 
norepinephrine bitartrate injection, solution, concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1724
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV) NOREPINEPHRINE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1724-610 in 1 CARTON04/24/2024
1NDC:70771-1724-14 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21634104/24/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1724) , ANALYSIS(70771-1724)

Revised: 7/2022
Document Id: 83e7fd9a-6919-473b-9abb-bdee9ad9aa76
Set id: 2f978ab3-59be-46ac-8621-2b4e757dd3fe
Version: 1
Effective Time: 20220726
 
Zydus Lifesciences Limited