FDA Product

Folic Acid

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Folic Acid

FDA Product Code

71610-716

Regulatory Information

NDC Product Code

71610-716

Application Number

ANDA211064

Marketing Category

C73584

Effective Date

June 15, 2023

Territorial Authority

USA

FDA Title

Folic Acid

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

Active Ingredients

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Quantity: 1 mg in 1 1

Code: 935E97BOY8

Class Code: ACTIB

Active Moieties

FOLIC ACID

Code: 935E97BOY8

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