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FDA Drug information

Cyanocobalamin

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


Effective Time

20220419

Version

1

Spl Product Data Elements

cyanocobalamin cyanocobalamin CYANOCOBALAMIN CYANOCOBALAMIN SODIUM CHLORIDE BENZYL ALCOHOL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER cyanocobalamin cyanocobalamin CYANOCOBALAMIN CYANOCOBALAMIN SODIUM CHLORIDE BENZYL ALCOHOL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER cyanocobalamin cyanocobalamin CYANOCOBALAMIN CYANOCOBALAMIN SODIUM CHLORIDE BENZYL ALCOHOL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Application Number

ANDA214655

Brand Name

Cyanocobalamin

Generic Name

cyanocobalamin

Product Ndc

70771-1689

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAMUSCULAR,SUBCUTANEOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1688-1 Cyanocobalamin Injection, USP 1,000 mcg/mL FOR IM OR SC USE ONLY 1 mL Multiple-dose Vial Rx only NDC 70771-1668-7 Cyanocobalamin Injection, USP 1,000 mcg/mL FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY 25 X 1 mL Multiple-dose Vials Rx only NDC 70771-1689-1 Cyanocobalamin Injection, USP 10,000 mcg/10 mL (1,000 mcg/mL) FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY Contains Benzyl Alcohol as a Preservative. 10 mL Multiple-Dose Vial Rx only NDC 70771-1689-6 Cyanocobalamin Injection, USP 10,000 mcg/10 mL (1,000 mcg/mL) FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY 10 X 10 mL Multiple-Dose Vials Rx only NDC 70771-1689-7 Cyanocobalamin Injection, USP 10,000 mcg/10 mL (1,000 mcg/mL) FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY 25 X 10 mL Multiple-Dose Vials Rx only NDC 70771-1690-1 Cyanocobalamin Injection, USP 30,000 mcg/30 mL (1,000 mcg/mL) FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY Contains Benzyl Alcohol as a Preservative. 30 mL Multiple-Dose Vial Rx only NDC 70771-1690-1 Cyanocobalamin Injection, USP 30,000 mcg/30 mL (1,000 mcg/mL) FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY 30 mL Multiple-Dose Vial – Carton Label Rx only NDC 70771-1690-5 Cyanocobalamin Injection, USP 30,000 mcg/30 mL (1,000 mcg/mL) FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY 5 X 30 mL Multiple-Dose Vials Rx only 1 mL vial label 25 x 1 mL carton label 10 mL vial label 10 x 10 mL carton 25 x 10 mL carton label 30 mL vial label 1 x 30 mL Carton label 5 x 30 mL carton label

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