Cyanocobalamin Injection, Usp

Cyanocobalamin Injection, Usp
SPL v1
SPL
SPL Set ID ef300a08-8212-40a9-847a-1b62348896dd
Routes
INTRAMUSCULAR SUBCUTANEOUS
Published
Effective Date 2022-04-19
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cyanocobalamin (1000 ug)
Inactive Ingredients
Sodium Chloride Benzyl Alcohol Sodium Phosphate, Dibasic, Heptahydrate Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-05-05

Description

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


Medication Information

Description

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

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


Structured Label Content

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


Advanced Ingredient Data


Raw Label Data

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