NDC Code(s) : 75854-310-30, 75854-310-03
Packager : Avion Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FeRivaFAferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-310
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS BISGLYCINATE(UNII: SFW1D987QV)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION110 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID175 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID1 mg
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN12 ug
BIOTIN(UNII: 6SO6U10H04)
(BIOTIN - UNII:6SO6U10H04) 		BIOTIN300 ug
CUPRIC OXIDE(UNII: V1XJQ704R4)
(CUPRIC CATION - UNII:8CBV67279L) 		CUPRIC CATION1 mg
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
(DOCUSATE - UNII:M7P27195AG) 		DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color red Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75854-310-3030 in 1 BOTTLE Type 0: Not a Combination Product02/01/2014
2NDC:75854-310-033 in 1 PACKET Type 0: Not a Combination Product02/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/02/2014 12/31/2015

PRINCIPAL DISPLAY PANEL

75854-310-30

FeRivaFA ™

Iron Supplement

110 mg Dual-Iron Delivery

with Quatrefolic

30 Capsules

Rx Only

Avion
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 30 capsules