NDC Code(s) : 69680-112-01, 69680-112-25, 69680-112-10, 69680-113-10, 69680-113-99, 69680-121-05, 69680-121-30, 69680-121-10
Packager : Vitruvias Therapeutics

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CyanocobalaminCyanocobalamin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69680-112
Route of Administration INTRAMUSCULAR 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)
Product Characteristics
Color RED Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69680-112-2525 in 1 BOX 01/02/2019
1NDC:69680-112-011 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:69680-112-1010 in 1 BOX 15/06/2019
2NDC:69680-112-011 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 ANDA209255 01/02/2019
CyanocobalaminCyanocobalamin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69680-113
Route of Administration INTRAMUSCULAR 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)
Product Characteristics
Color RED Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69680-113-9910 in 1 BOX 01/02/2019
1NDC:69680-113-1010 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 ANDA209255 01/02/2019
CyanocobalaminCyanocobalamin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69680-121
Route of Administration INTRAMUSCULAR 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)
Product Characteristics
Color RED Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69680-121-055 in 1 BOX 02/12/2020
130 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
2NDC:69680-121-301 in 1 BOX 15/09/2021
230 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
3NDC:69680-121-1010 in 1 BOX 15/09/2021
330 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 ANDA209255 02/12/2020

LABELER - Vitruvias Therapeutics(079200795)

Establishment
Name Address ID/FEI Business Operations
UBI Pharma Inc. 658871159 MANUFACTURE(69680-112, 69680-113, 69680-121), PACK(69680-112, 69680-113, 69680-121), ANALYSIS(69680-112, 69680-113, 69680-121)

PRINCIPAL DISPLAY PANEL

Cyanocobalamin
Injection, USP
1000 mcg/mL

NDC 69680–112–10
10 x 1 mL VIALS

For Intramuscular or Subcutaneous Use Only
Each mL contains: Cyanocobalamin 1000 mcg, Sodium Chloride 0.9%,
Benzyl Alcohol 1.5%, Water for Injection q.s. pH (range 4.5 - 7.0)
adjusted with Hydrochloric Acid and/or Sodium Hydroxide.
WARNING: PROTECT FROM LIGHT. Store at 20° to 25°C (68° to
77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP
Controlled Room Temperature). Directions for Use: See Package Insert.

Rx Only

Product of France
Mfd. by:
UBI Pharma, Inc.
Taiwan

Mfd. for:
Vitruvias Therapeutics
Auburn, AL 36830

Rev. 04/19

PRINCIPAL DISPLAY PANEL - 1 mL Vial Box Label

PRINCIPAL DISPLAY PANEL

Cyanocobalamin
Injection, USP
10,000 mcg/10 mL (1,000 mcg/mL)

NDC 69680–113–99
10 x 10 mL
MULTIPLE DOSE VIALS

For Intramuscular or Subcutaneous Use Only
Each mL contains: Cyanocobalamin 1000 mcg, Benzyl Alcohol 1.5%,
Sodium Chloride 0.9%, Water for Injection q.s. pH (range 4.5 - 7.0)
adjusted with Hydrochloric Acid and/or Sodium Hydroxide.
WARNING: PROTECT FROM LIGHT. Store at 20° to 25°C (68° to 77°F);
excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled
Room Temperature).
Directions for Use: See Package Insert.
Product of France

Rx Only

Rev. 06/18

Mfd. by:
UBI Pharma, Inc.
Taiwan

Mfd. for:
Vitruvias Therapeutics
Auburn, AL 36830

PRINCIPAL DISPLAY PANEL - 10 mL Vial Box

PRINCIPAL DISPLAY PANEL

Cyanocobalamin
Injection, USP
30,000 mcg/30 mL (1,000 mcg/mL)

NDC 69680–121–05
5 x 30 mL
MULTIPLE DOSE VIALS

For Intramuscular or Subcutaneous Use Only
Each mL contains: Cyanocobalamin 1000 mcg, Benzyl Alcohol 1.5%,
Sodium Chloride 0.9%, Water for Injection q.s. pH (range 4.5 - 7.0)
adjusted with Hydrochloric Acid and/or Sodium Hydroxide.
WARNING: PROTECT FROM LIGHT. Store at 20° to 25°C (68° to 77°F);
excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled
Room Temperature).
Directions for Use: See Package Insert.
Product of France

Rx Only

Rev. 06/18

Mfd. by:
UBI Pharma, Inc.
Taiwan

Mfd. for:
Vitruvias Therapeutics
Auburn, AL 36830

PRINCIPAL DISPLAY PANEL - 30 mL Vial Box