MedPath

Chromagen

Iron Supplement Chromagen

Approved
Approval ID

13c5ed58-6333-498f-9ace-1049d7ae3552

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 23, 2024

Manufacturers
FDA

Avion Pharmaceuticals, LLC

DUNS: 040348516

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75854-320
Product Classification
G
Generic Name
ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2021
FDA Product Classification

INGREDIENTS (17)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
GELATIN TYPE B BOVINE (200 BLOOM)Inactive
Code: A7JR5F8DLH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAROBInactive
Code: 5MG5Z946UO
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
FERROUS ASPARTO GLYCINATEActive
Quantity: 25 mg in 1 1
Code: H7426RGB3L
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 50 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
LEVOMEFOLIC ACIDActive
Quantity: 750 ug in 1 1
Code: 8S95DH25XC
Classification: ACTIB
FOLIC ACIDActive
Quantity: 250 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 10 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ZINCActive
Quantity: 12 mg in 1 1
Code: J41CSQ7QDS
Classification: ACTIB
INTRINSIC FACTORActive
Quantity: 100 mg in 1 1
Code: 70BT6OQT2Q
Classification: ACTIB

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Chromagen - FDA Drug Approval Details