Label: CYANOCOBALAMIN injection, solution
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NDC Code(s):
70771-1688-1,
70771-1688-7,
70771-1689-1,
70771-1689-6, view more70771-1689-7, 70771-1690-1, 70771-1690-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cyanocobalamin Injection, USP
1,000 mcg/mL
FOR IM OR SC USE ONLY
1 mL Multiple-dose Vial
Rx only
Cyanocobalamin Injection, USP
1,000 mcg/mL
FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY
25 X 1 mL Multiple-dose Vials
Rx only
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
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
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
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
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
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
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INGREDIENTS AND APPEARANCE
CYANOCOBALAMIN
cyanocobalamin injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1688 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 1000 ug in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1688-7 25 in 1 VIAL 05/05/2022 1 NDC:70771-1688-1 1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214655 05/05/2022 CYANOCOBALAMIN
cyanocobalamin injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1689 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 1000 ug in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1689-6 10 in 1 VIAL 05/05/2022 1 NDC:70771-1689-1 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:70771-1689-7 25 in 1 CARTON 05/05/2022 2 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214655 05/05/2022 CYANOCOBALAMIN
cyanocobalamin injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1690 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 1000 ug in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1690-1 1 in 1 CARTON 05/05/2022 1 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:70771-1690-5 5 in 1 CARTON 05/05/2022 2 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 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 Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1688, 70771-1689, 70771-1690) , ANALYSIS(70771-1688, 70771-1689, 70771-1690)