RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride injection
Zydus Lifesciences Limited

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Ranitidine Injection, USP

PRINCIPAL DISPLAY PANEL - 2 mL Vial Container Label

NDC 65841-763-02

50 mg/2 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

2 mL Single-Use Vial

Sterile

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton Label

NDC 65841-763-02

Ranitidine Injection, USP

50 mg/2 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

10 X 2 mL Single-Use Vials

Rx only

Sterile

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 6 mL Vial Container Label

NDC 65841-764-06

Ranitidine Injection, USP

150 mg/6 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

6 mL Multi-Dose Vial

Sterile

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 6 mL Vial Carton Label

NDC 65841-764-06

Ranitidine Injection, USP

150 mg/6 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

6 mL Multi-Dose Vial

Sterile

Rx only

Zydus Pharmaceuticals

RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-763
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PHENOL (UNII: 339NCG44TV)	5 mg in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-763-02	10 in 1 CARTON	03/01/2013	03/25/2025
1		2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091534	03/01/2013	06/26/2025

RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-764
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PHENOL (UNII: 339NCG44TV)	5 mg in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-764-06	6 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product	03/01/2013	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091534	03/01/2013	06/26/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-763, 65841-764) , MANUFACTURE(65841-763, 65841-764)

Revised: 6/2025

Document Id: e8ab4530-a4cf-4763-9eb3-db0981ed3bc3

Set id: 9268c1df-bcf3-4899-896d-044492802a33

Version: 8

Effective Time: 20250626

Zydus Lifesciences Limited