This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Cyanocobalamin

Read time: 1 mins
Marketing start date: 23 Dec 2024
...
 

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

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.