NDC Code(s) : 68083-437-01, 68083-437-10
Packager : Gland Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Norepinephrine bitartrate Norepinephrine bitartrate INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-437
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NOREPINEPHRINE BITARTRATE(UNII: IFY5PE3ZRW)
(NOREPINEPHRINE - UNII:X4W3ENH1CV) 		NOREPINEPHRINE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-437-1010 in 1 CARTON 05/12/2021
1NDC:68083-437-014 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214323 05/12/2021

LABELER - Gland Pharma Limited(918601238)

Establishment
Name Address ID/FEI Business Operations
GLAND PHARMA LIMITED 858971074 ANALYSIS(68083-437), MANUFACTURE(68083-437), PACK(68083-437)

PRINCIPAL DISPLAY PANEL

Container Label :

NDC 68083-437-01

Norepinephrine  Bitartrate

Injection, USP
4 mg/4 mL  (1 mg/mL)

FOR INTRAVENOUS INFUSION ONLY

4 mL Single-Dose Vial               Rx only
norepinephrine-bitartrate-spl-container
Carton Label :

NDC 68083-437-10

Norepinephrine  Bitartrate  Injection, USP

4 mg/4 mL  (1 mg/mL)

FOR INTRAVENOUS INFUSION ONLY

10 x 4 mL Single-Dose Vials    Rx only

norepinephrine-bitartrate-spl-container
Sticker Label:

norepinephrine-bitartrate-spl-container