NDC Code(s) : 0143-9621-01, 0143-9621-25, 0143-9620-01, 0143-9620-10, 0143-9619-01, 0143-9619-10
Packager : West-Ward Pharmaceuticals Corp

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
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
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
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

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

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

NDC 0143-9621-25
Rx only
Cyanocobalamin
Injection, USP
1,000 mcg/mL
For INTRAMUSCULAR or
SUBCUTANEOULS USE ONLY
Contains Benzyl Alcohol
as a Preservative

25 x 1 mL Vials
Each mL contains: Cyanocobalamin 1,000 mcg,
Sodium Chloride 9 mg, Benzyl Alcohol
0.015 mL in Water for Injection. pH 4.5-7.0
adjusted with Hydrochloric Acid and/or
Sodium Hydroxide, if needed. Contains
no more than 200 mcg/L of aluminum.
WARNING: PROTECT FROM LIGHT.
Store at 20º to 25ºC (68º to 77ºF),
excursions permitted to 15º to 30ºC
(59º to 86ºF) [See USP Controlled
Room Temperature].
USUAL DOSAGE: See package insert.

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

PRINCIPAL DISPLAY PANEL

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

Each mL contains: Cyanocobalamin
1,000 mcg, Sodium Chloride 9 mg,
Benzyl Alcohol 0.015 mL in Water for
Injection. pH 4.5-7.0 adjusted with
Hydrochloric Acid and/or Sodium
Hydroxide, if needed. Contains no
more than 200 mcg/L of aluminum.
WARNING: PROTECT FROM LIGHT.
Store at 20º to 25ºC (68º to 77ºF),
USUAL DOSAGE: See package insert.

NDC 0143-9620-01 10 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 10,000 mcg/10 mL (1,000 mcg/mL) For INTRAMUSCULAR or SUBCUTANEOULS USE ONLY Contains Benzyl Alcohol as a Preservative Each mL contains: Cyanocobalamin 1,000 mcg, Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mL in Water for Injection. pH 4.5-7.0 adjusted with Hydrochloric Acid and/or Sodium Hydroxide, if needed. Contains no more than 200 mcg/L of aluminum. WARNING: PROTECT FROM LIGHT. Store at 20º to 25ºC (68º to 77ºF), USUAL DOSAGE: See package insert.

NDC 0143-9620-10
Rx only
Cyanocobalamin
Injection, USP
10,000 mcg/10 mL
(1,000 mcg/mL)
For INTRAMUSCULAR or
SUBCUTANEOULS USE ONLY
Contains Benzyl Alcohol
as a Preservative
10 x 10 mL Multiple Dose Vials
Each mL contains: Cyanocobalamin 1,000 mcg,
Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mL
in Water for Injection. pH 4.5-7.0 adjusted
with Hydrochloric Acid and/or Sodium
Hydroxide, if needed. Contains no more
than 200 mcg/L of aluminum.
WARNING: PROTECT FROM LIGHT.
Store at 20º to 25ºC (68º to 77ºF), excursions
permitted to 15º to 30ºC (59º to 86ºF)
[See USP Controlled Room Temperature].
USUAL DOSAGE: See package insert.

NDC 0143-9620-01 10 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 10,000 mcg/10 mL (1,000 mcg/mL) For INTRAMUSCULAR or SUBCUTANEOULS USE ONLY Contains Benzyl Alcohol as a Preservative Each mL contains: Cyanocobalamin 1,000 mcg, Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mL in Water for Injection. pH 4.5-7.0 adjusted with Hydrochloric Acid and/or Sodium Hydroxide, if needed. Contains no more than 200 mcg/L of aluminum. WARNING: PROTECT FROM LIGHT. Store at 20º to 25ºC (68º to 77ºF), USUAL DOSAGE: See package insert.

PRINCIPAL DISPLAY PANEL

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

Each mL contains: Cyanocobalamin
1,000 mcg, Sodium Chloride 9 mg,
Benzyl Alcohol 0.015 mL in Water for
Injection. pH 4.5-7.0 adjusted with
Hydrochloric Acid and/or Sodium
Hydroxide, if needed. Contains no
more than 200 mcg/L of aluminum.
WARNING: PROTECT FROM LIGHT.
Store at 20º to 25ºC (68º to 77ºF),
USUAL DOSAGE: See package insert.

NDC 0143-9619-01 30 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 30,000 mcg/30 mL (1,000 mcg/mL) For INTRAMUSCULAR or SUBCUTANEOULS USE ONLY Contains Benzyl Alcohol as a Preservative Each mL contains: Cyanocobalamin 1,000 mcg, Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mL in Water for Injection. pH 4.5-7.0 adjusted with Hydrochloric Acid and/or Sodium Hydroxide, if needed. Contains no more than 200 mcg/L of aluminum. WARNING: PROTECT FROM LIGHT. Store at 20º to 25ºC (68º to 77ºF), USUAL DOSAGE: See package insert.

NDC 0143-9619-10
Rx only
Cyanocobalamin
Injection, USP
30,000 mcg/30 mL
(1,000 mcg/mL)
For INTRAMUSCULAR or
SUBCUTANEOULS USE ONLY
Contains Benzyl Alcohol
as a Preservative
10 x 30 mL Multiple Dose Vials
Each mL contains: Cyanocobalamin 1,000 mcg,
Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mL
in Water for Injection. pH 4.5-7.0 adjusted
with Hydrochloric Acid and/or Sodium
Hydroxide, if needed. Contains no more
than 200 mcg/L of aluminum.
WARNING: PROTECT FROM LIGHT.
Store at 20º to 25ºC (68º to 77ºF), excursions
permitted to 15º to 30ºC (59º to 86ºF)
[See USP Controlled Room Temperature].
USUAL DOSAGE: See package insert.

NDC 0143-9619-01 30 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 30,000 mcg/30 mL (1,000 mcg/mL) For INTRAMUSCULAR or SUBCUTANEOULS USE ONLY Contains Benzyl Alcohol as a Preservative Each mL contains: Cyanocobalamin 1,000 mcg, Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mL in Water for Injection. pH 4.5-7.0 adjusted with Hydrochloric Acid and/or Sodium Hydroxide, if needed. Contains no more than 200 mcg/L of aluminum. WARNING: PROTECT FROM LIGHT. Store at 20º to 25ºC (68º to 77ºF), USUAL DOSAGE: See package insert.