RANITIDINE HYDROCHLORIDE - ranitidine hydrochloride injection, solution
Zydus Lifesciences Limited

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Ranitidine Injection, USP
Pharmacy Bulk Package—Not for Direct Infusion
Rx only

PRINCIPAL DISPLAY PANEL - 40 mL Vial Container Label

NDC 72785-0001-1

Ranitidine Injection USP

1000 mg/40 mL

(25 mg/mL*)

40-mL Pharmacy Bulk package – Not for Direct Infusion

Sterile

Rx only

Zydus pharmaceuticals

PRINCIPAL DISPLAY PANEL - 40 mL Vial Carton Label

NDC 72785-0001-1

Ranitidine Injection USP

1000 mg/40 mL

(25 mg/mL*)

40-mL Pharmacy Bulk Package – Not for Direct Infusion

Sterile

Rx only

Zydus pharmaceuticals

RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injection, solution

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)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0001-1	1 in 1 CARTON	02/21/2019
1		40 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091534	02/21/2019

Labeler - Zydus Lifesciences Limited (873671928)

Registrant - Zydus Lifesciences Limited (873671928)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		873671928	ANALYSIS(72785-0001) , MANUFACTURE(72785-0001)

Revised: 11/2022

Document Id: 2c7f5efb-48f9-42f3-885c-7012660019e3

Set id: 82ec17ea-a7e0-43a2-bc23-f96c3aaaa045

Version: 4

Effective Time: 20221105

Zydus Lifesciences Limited

Ranitidine Injection, USPPharmacy Bulk Package—Not for Direct InfusionRx only