NDC Code(s) : 70069-005-01, 70069-005-10, 70069-172-01, 70069-172-10, 70069-172-25
Packager : Somerset Therapeutics, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

cyanocobalamincyanocobalamin INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-005
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)15 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color RED (Red Colored Clear Solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70069-005-1025 in 1 CARTON 12/11/2015
1NDC:70069-005-011 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206503 12/11/2015
cyanocobalamincyanocobalamin INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-172
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)15 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color RED (Red Colored Clear Solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70069-172-1010 in 1 CARTON 27/06/2017
1NDC:70069-172-0110 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:70069-172-2525 in 1 CARTON 27/06/2017
2NDC:70069-172-0110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206503 06/27/2017

LABELER - Somerset Therapeutics, LLC(079947873)

REGISTRANT - Somerset Therapeutics, LLC(079947873)

Establishment
Name Address ID/FEI Business Operations
Somerset Therapeutics Limited 677236695 ANALYSIS(70069-005, 70069-172), LABEL(70069-005, 70069-172), MANUFACTURE(70069-005, 70069-172), PACK(70069-005, 70069-172)

Establishment
Name Address ID/FEI Business Operations
Maiva Pharma Private Limited 725656438 ANALYSIS(70069-005), LABEL(70069-005), MANUFACTURE(70069-005), PACK(70069-005)

PRINCIPAL DISPLAY PANEL

Cyanocobalamin Injection, USP

1 mL Container Label

NDC 70069-005-01

Container LabelContainer LabelContainer Label

Cyanocobalamin Injection, USP

1 mL Carton Label

NDC 70069-005-10

Container LabelContainer LabelCarton Label

Cyanocobalamin Injection, USP

10 mL Container Label

NDC 70069-172-01

Container Labelcontainer Label

Cyanocobalamin Injection, USP

10 mL Carton Label – Pack of 25's

NDC 70069-172-25

Container Labelcarton label

Cyanocobalamin Injection, USP

10 mL Carton Label – Pack of 10's

NDC 70069-172-10

Container Labelcarton-label