MedPath

Folic Acid

Rx only

Approved
Approval ID

0eea15e4-7e5d-44e9-818b-a0bdf5271c78

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 25, 2023

Manufacturers
FDA

Modavar Pharmaceuticals LLC

DUNS: 858949204

Products 1

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

Folic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72241-050
Application NumberANDA202437
Product Classification
M
Marketing Category
C73584
G
Generic Name
Folic Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Folic Acid - FDA Drug Approval Details