HYDROCORTISONE SODIUM SUCCINATE injection

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1966-1

Hydrocortisone sodium succinate for injection, USP

100 mg/vial

For Intravenous or Intramuscular use

Rx only

INGREDIENTS AND APPEARANCE

HYDROCORTISONE SODIUM SUCCINATE 
hydrocortisone sodium succinate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1966
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	100 mg  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1966-1	1 in 1 CARTON	05/09/2026
1		2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217191	05/09/2026

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1966) , ANALYSIS(70771-1966) , API MANUFACTURE(70771-1966)