NDC Code(s) : 75854-320-30
Packager : Avion Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chromagenferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS ASPARTO GLYCINATE(UNII: H7426RGB3L)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION25 mg
FERROUS FUMARATE(UNII: R5L488RY0Q)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION50 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID60 mg
LEVOMEFOLIC ACID(UNII: 8S95DH25XC)
(LEVOMEFOLIC ACID - UNII:8S95DH25XC) 		LEVOMEFOLIC ACID750 ug
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID250 ug
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN10 ug
ZINC(UNII: J41CSQ7QDS)
(ZINC - UNII:J41CSQ7QDS) 		ZINC12 mg
INTRINSIC FACTOR(UNII: 70BT6OQT2Q)
(INTRINSIC FACTOR - UNII:70BT6OQT2Q) 		INTRINSIC FACTOR100 mg
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL(UNII: 241ATL177A)
GELATIN TYPE B BOVINE (200 BLOOM)(UNII: A7JR5F8DLH)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
CAROB(UNII: 5MG5Z946UO)
CARAMEL(UNII: T9D99G2B1R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
YELLOW WAX(UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color blue (pearlescent dark blue) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code CH75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75854-320-3030 in 1 BOTTLE Type 0: Not a Combination Product23/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/10/2017

LABELER - Avion Pharmaceuticals, LLC(040348516)

Establishment
Name Address ID/FEI Business Operations
Avion Pharmaceuticals, LLC 040348516 manufacture(75854-320)

PRINCIPAL DISPLAY PANEL

75854-320-30

SUGAR FREE

LACTOSE FREE

Rx Only

Dietary Supplement

Chromagen™

30 softgels

chromagen label