Cyanocobalamin

CYANOCOBALAMIN — cyanocobalamin injection, solution
Zydus Lifesciences Limited

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
CYANOCOBALAMIN
cyanocobalamin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1688
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
BENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1688-7 25 VIAL, MULTI-DOSE in 1 VIAL contains a VIAL, MULTI-DOSE (70771-1688-1)
1 NDC:70771-1688-1 1 mL in 1 VIAL, MULTI-DOSE This package is contained within the VIAL (70771-1688-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214655 05/05/2022
CYANOCOBALAMIN
cyanocobalamin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1689
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
BENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1689-6 10 VIAL, MULTI-DOSE in 1 VIAL contains a VIAL, MULTI-DOSE (70771-1689-1)
1 NDC:70771-1689-1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the VIAL (70771-1689-6)
2 NDC:70771-1689-7 25 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70771-1689-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214655 05/05/2022
CYANOCOBALAMIN
cyanocobalamin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1690
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
BENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1690-1 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70771-1690-1)
2 NDC:70771-1690-5 5 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70771-1690-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214655 05/05/2022
Labeler — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 873671928 MANUFACTURE (70771-1688), MANUFACTURE (70771-1689), MANUFACTURE (70771-1690), ANALYSIS (70771-1688), ANALYSIS (70771-1689), ANALYSIS (70771-1690)

Revised: 04/2022 Zydus Lifesciences Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.