NDC Code(s) : 76439-209-30, 76439-209-90
Packager : Virtus Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Virt-Vitefolic acid, pyridoxine hydrochloride and cyanocobalamin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-209
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID2.5 mg
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE HYDROCHLORIDE25 mg
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN1 mg
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
STEARIC ACID(UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYDEXTROSE(UNII: VH2XOU12IE)
TALC(UNII: 7SEV7J4R1U)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
C10-18 TRIGLYCERIDES(UNII: 43AGM4PHPI)
PIGMENT RED 48(UNII: 07XHK4SAV6)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code V209
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76439-209-3030 in 1 BOTTLE
2NDC:76439-209-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/04/2014

PRINCIPAL DISPLAY PANEL

Virtus
PHARMACEUTICALS

Product Code: 76439-209-90

Virt-Vite
Tablets

Prescription Dietary Supplement

Rx

90 Tablets

PRINCIPAL DISPLAY PANEL - 30 tablets