NDC Code(s) : 0143-9621-01, 0143-9621-25, 0143-9620-01, 0143-9620-10, 0143-9619-01, 0143-9619-10
Packager : Hikma Pharmaceuticals USA Inc.

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:0143-9621
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
WATER(UNII: 059QF0KO0R)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9621-2525 in 1 BOX 20/10/1971
1NDC:0143-9621-011 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 ANDA080515 10/20/1971
Cyanocobalamincyanocobalamin INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9620
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
WATER(UNII: 059QF0KO0R)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9620-1010 in 1 BOX 20/10/1971
1NDC:0143-9620-0110 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 ANDA080515 10/20/1971
Cyanocobalamincyanocobalamin INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9619
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
WATER(UNII: 059QF0KO0R)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9619-1010 in 1 BOX 20/10/1971
1NDC:0143-9619-0130 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 ANDA080515 10/20/1971

LABELER - Hikma Pharmaceuticals USA Inc.(001230762)

Establishment
Name Address ID/FEI Business Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A 452742943 analysis(0143-9621, 0143-9620, 0143-9619), label(0143-9621, 0143-9620, 0143-9619), manufacture(0143-9621, 0143-9620, 0143-9619), pack(0143-9621, 0143-9620, 0143-9619)

PRINCIPAL DISPLAY PANEL

NDC 0143-9621-01    1 mL Vial
Cyanocobalamin
Injection, USP
Rx only
1,000 mcg/mL
For IM or SC use ONLY
Protect from light
Contains Benzyl Alcohol

1000 vial

NDC 0143-9621-25   Rx only
Cyanocobalamin
Injection, USP
1,000 mcg/mL
For Intramuscular or
Subcutaneous use ONLY
Contains Benzyl Alcohol
as a Preservative
25 x 1 mL Vials

1000 vial

PRINCIPAL DISPLAY PANEL

NDC 0143-9620-01   10 mL Multiple Dose Vial
Cyanocobalamin
Injection, USP
Rx only
10,000 mcg per 10 mL
(1,000 mcg/mL)
For Intramuscular or
Subcutaneous use ONLY
Contains Benzyl Alcohol
as a Preservative

10000 vial

NDC 0143-9620-10   Rx only
Cyanocobalamin
Injection, USP
10,000 mcg per 10 mL
(1,000 mcg/mL)
For Intramuscular or
Subcutaneous use ONLY
Contains Benzyl Alcohol
as a Preservative
10 x 10 mL Multiple Dose Vials

10000 vial

PRINCIPAL DISPLAY PANEL

NDC 0143-9619-01   30 mL Multiple Dose Vial
Cyanocobalamin
Injection, USP
Rx only
30,000 mcg per 30 mL
(1,000 mcg/mL)
For Intramuscular or
Subcutaneous use ONLY
Contains Benzyl Alcohol
as a Preservative

30000 vial

NDC 0143-9619-10    Rx only
Cyanocobalamin
Injection, USP
30,000 mcg per 30 mL
(1,000 mcg/mL)
For Intramuscular or
Subcutaneous use ONLY
Contains Benzyl Alcohol
as a Preservative
10 x 30 mL Multiple Dose Vials

30000 vial

NDC 0143-9619-01    Rx only
Cyanocobalamin
Injection, USP
30,000 mcg per 30 mL
(1,000 mcg/mL)
For Intramuscular or
Subcutaneous use ONLY
Contains Benzyl Alcohol
as a Preservative
1 x 30 mL Multiple Dose Vials

30000 vial

PRINCIPAL DISPLAY PANEL

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