NDC Code(s) : 76439-340-30
Packager : Virtus Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Virt-Pn DHALEVOMEFOLATE CALCIUM, PYRIDOXINE, CALCIUM CARBONATE, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, CYANOCOBALAMIN, FERROUS FUMARATE, MAGNESIUM OXIDE, and DOCONEXENT CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-340
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM(UNII: A9R10K3F2F)
(LEVOMEFOLIC ACID - UNII:8S95DH25XC) 		LEVOMEFOLATE CALCIUM1 mg
PYRIDOXINE(UNII: KV2JZ1BI6Z)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE25 mg
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CARBONATE140 mg
SODIUM ASCORBATE(UNII: S033EH8359)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		SODIUM ASCORBATE85 mg
CHOLECALCIFEROL(UNII: 1C6V77QF41)
(CHOLECALCIFEROL - UNII:1C6V77QF41) 		CHOLECALCIFEROL200 [iU]
.ALPHA.-TOCOPHEROL, D-(UNII: N9PR3490H9)
(.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) 		.ALPHA.-TOCOPHEROL, D-10 [iU]
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN12 ug
FERROUS FUMARATE(UNII: R5L488RY0Q)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS FUMARATE27 mg
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
(MAGNESIUM CATION - UNII:T6V3LHY838) 		MAGNESIUM OXIDE45 mg
DOCONEXENT(UNII: ZAD9OKH9JC)
(DOCONEXENT - UNII:ZAD9OKH9JC) 		DOCONEXENT300 mg
Inactive Ingredients
Ingredient Name Strength
Annatto(UNII: 6PQP1V1B6O)
Ethyl Vanillin(UNII: YC9ST449YJ)
Gelatin(UNII: 2G86QN327L)
Glycerin(UNII: PDC6A3C0OX)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Egg Phospholipids(UNII: 1Z74184RGV)
Citrus Sinensis Fruit Oil(UNII: WV48LBL15Q)
Water(UNII: 059QF0KO0R)
Soybean Oil(UNII: 241ATL177A)
Yellow Wax(UNII: 2ZA36H0S2V)
Potassium Citrate Anhydrous(UNII: 86R1NVR0HW)
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 25 mm
Flavor Imprint Code 340
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76439-340-3030 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/12/2012

PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

Product Code: 76439-340-30

Virt-PN
DHA Softgels

Rx

30 Softgels

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label