SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial Label

NDC 70771-1352-1

Succinylcholine Chloride Injection, USP

200 mg/10 mL (20 mg/mL)

For Intravenous or Intramuscular use.

10 mL Multiple-dose Vial

Rx only

Zydus Pharmaceuticals

Carton Label

NDC 70771-1352-7

Succinylcholine Chloride Injection, USP

200 mg/10 mL (20 mg/mL)

For Intravenous or Intramuscular use.

Store in refrigerator 2º to 8ºC (36º to 46ºF).

25 (25 x 1) 10 mL Multiple-dose Vial

Rx only

Zydus Pharmaceuticals

SUCCINYLCHOLINE CHLORIDE
succinylcholine chloride injection, solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)	SUCCINYLCHOLINE CHLORIDE	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T)	1.8 mg in 1 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.2 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1352-7	25 in 1 TRAY	05/10/2018
1	NDC:70771-1352-1	10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209467	05/10/2018

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1352) , MANUFACTURE(70771-1352)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1352) , ANALYSIS(70771-1352)