Ranitidine Hydrochloride

RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride injection, solution
Cadila Healthcare Limited

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

vial label
(click image for full-size original)

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

carton label
(click image for full-size original)
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0001
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72785-0001-1 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON contains a VIAL, PHARMACY BULK PACKAGE
1 40 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the CARTON (72785-0001-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091534 02/21/2019
Labeler — Cadila Healthcare Limited (873671928)
Registrant — Cadila Healthcare Limited (873671928)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 873671928 ANALYSIS (72785-0001), MANUFACTURE (72785-0001)

Revised: 07/2020 Cadila Healthcare Limited

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