CYANOCOBALAMIN - cyanocobalamin injection, solution 
Zydus Lifesciences Limited

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Cyanocobalamin Injection, USP

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

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

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

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

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

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

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

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
CYANOCOBALAMIN 
cyanocobalamin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1688
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1688-725 in 1 VIAL05/05/2022
1NDC:70771-1688-11 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21465505/05/2022
CYANOCOBALAMIN 
cyanocobalamin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1689
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1689-610 in 1 VIAL05/05/2022
1NDC:70771-1689-110 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:70771-1689-725 in 1 CARTON05/05/2022
210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21465505/05/2022
CYANOCOBALAMIN 
cyanocobalamin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1690
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1690-11 in 1 CARTON05/05/2022
130 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:70771-1690-55 in 1 CARTON05/05/2022
230 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21465505/05/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1688, 70771-1689, 70771-1690) , ANALYSIS(70771-1688, 70771-1689, 70771-1690)

Revised: 4/2022
Document Id: 8940ec64-b0cd-4f10-bc19-251146c9e552
Set id: ef300a08-8212-40a9-847a-1b62348896dd
Version: 1
Effective Time: 20220419
 
Zydus Lifesciences Limited