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FDA Drug information

Ranitidine Hydrochloride

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221105

Version

7

Spl Product Data Elements

Ranitidine Hydrochloride Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE RANITIDINE PHENOL POTASSIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC Ranitidine Hydrochloride Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE RANITIDINE PHENOL POTASSIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC

Application Number

ANDA091534

Brand Name

Ranitidine Hydrochloride

Generic Name

Ranitidine Hydrochloride

Product Ndc

65841-764

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAMUSCULAR,INTRAVENOUS

Package Label 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 vial label carton label single-use Vial Label multidose carton label multidose

Drug section

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