SUCCINYLCHOLINE CHLORIDE injection, solution

Succinylcholine Chloride by

Drug Labeling and Warnings

Succinylcholine Chloride by is a Prescription medication manufactured, distributed, or labeled by Liva Pharmaceuticals Limited, Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial Label

NDC: 72785-0010-1

Succinylcholine Chloride Injection, USP

200 mg/10 mL (20 mg/mL)

For Intravenous or Intramuscular use.

10 mL Multiple-dose Vial

Rx only

Carton Label

NDC: 72785-0010-7

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 x 10 mL Multiple-dose Vial

Rx only

INGREDIENTS AND APPEARANCE

SUCCINYLCHOLINE CHLORIDE 
succinylcholine chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72785-0010
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72785-0010-7	25 in 1 TRAY	05/10/2018
1	NDC: 72785-0010-1	10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

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

Labeler - Liva Pharmaceuticals Limited (873671928)

Registrant - Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Liva Pharmaceuticals Limited		873671928	MANUFACTURE(72785-0010) , ANALYSIS(72785-0010)