Cyanocobalamin Injection, Solution
FDA Label NDC 70771-1689

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Cyanocobalamin (NDC 70771-1689). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

1 mL Vial Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 01)

1 mL Vial Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 01)

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

25 X 1 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 02)

25 X 1 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 02)

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

10 mL Vial Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 03)

10 mL Vial Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 03)

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

10 X 10 mL Carton (8940ec64 B0cd 4f10 Bc19 251146c9e552 04)

10 X 10 mL Carton (8940ec64 B0cd 4f10 Bc19 251146c9e552 04)

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

25 X 10 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 05)

25 X 10 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 05)

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

30 mL Vial Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 06)

30 mL Vial Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 06)

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

1 X 30 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 07)

1 X 30 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 07)

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

5 X 30 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 08)

5 X 30 mL Carton Label (8940ec64 B0cd 4f10 Bc19 251146c9e552 08)

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