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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 2 mL Vial Container Label
NDC 65841-763-02
Ranitidine Injection, USP
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
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INGREDIENTS AND APPEARANCE
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-763 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 5 mg in 1 mL POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-763-02 10 in 1 CARTON 03/01/2013 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 ANDA091534 03/01/2013 RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-764 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 5 mg in 1 mL POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-764-06 6 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091534 03/01/2013 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-763, 65841-764) , MANUFACTURE(65841-763, 65841-764)