NDC Code(s) : 76439-243-30
Packager : Virtus Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Virt-PN Plusfolic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-243
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 ACID1 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID85 mg
CHOLECALCIFEROL(UNII: 1C6V77QF41)
(CHOLECALCIFEROL - UNII:1C6V77QF41) 		CHOLECALCIFEROL200 [iU]
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
(.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) 		.ALPHA.-TOCOPHEROL10 [iU]
PYRIDOXINE(UNII: KV2JZ1BI6Z)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE25 mg
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN12 ug
BIOTIN(UNII: 6SO6U10H04)
(BIOTIN - UNII:6SO6U10H04) 		BIOTIN250 ug
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CATION140 mg
FERROUS FUMARATE(UNII: R5L488RY0Q)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION28 mg
POTASSIUM IODIDE(UNII: 1C4QK22F9J)
(IODIDE ION - UNII:09G4I6V86Q) 		POTASSIUM IODIDE150 ug
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
(MAGNESIUM CATION - UNII:T6V3LHY838) 		MAGNESIUM OXIDE45 mg
DOCONEXENT(UNII: ZAD9OKH9JC)
(DOCONEXENT - UNII:ZAD9OKH9JC) 		DOCONEXENT300 mg
ICOSAPENT(UNII: AAN7QOV9EA)
(ICOSAPENT - UNII:AAN7QOV9EA) 		ICOSAPENT40 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX(UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
SOYBEAN OIL(UNII: 241ATL177A)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
ETHYL VANILLIN(UNII: YC9ST449YJ)
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 24 mm
Flavor Imprint Code 243
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76439-243-3030 in 1 BOTTLE Type 0: Not a Combination Product01/03/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2013 05/05/2016

PRINCIPAL DISPLAY PANEL

NDC 76439-243-30         Rx Only

Virt-PN
Plus

Softgels

Virtus
PHARMACEUTICALS

Rx

30 Softgels

PRINCIPAL DISPLAY PANEL - 30 tablets