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Folixapure

Folixapure Tablets [Folate (as folic acid) 1700 mcg DFE (1000 mcg folic acid), VitaminD3 (cholecalciferol) 125 mcg (5000IU)] Rx Only

Approved
Approval ID

aa1daf3a-9673-6996-e053-2a95a90a5f87

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 2023

Manufacturers
FDA

PureTek Corporation

DUNS: 785961046

Products 1

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

Folic Acid, Vitamin D3

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59088-163
Product Classification
G
Generic Name
Folic Acid, Vitamin D3
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification

INGREDIENTS (7)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
VITAMIN DActive
Quantity: 125 ug in 1 1
Code: 9VU1KI44GP
Classification: ACTIB

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Folixapure - FDA Drug Approval Details