FDA Product

Prometrium

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

Basic Information

Product Name

Prometrium

FDA Product Code

72989-372

Regulatory Information

NDC Product Code

72989-372

Application Number

NDA019781

Marketing Category

C73594

Effective Date

March 7, 2024

Territorial Authority

USA

FDA Title

PROMETRIUM (progesterone, USP)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerAcertis Pharmaceuticals, LLC

DUNS Number

116930555

Active Ingredients

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Quantity: 100 mg in 1 1

Code: 4G7DS2Q64Y

Class Code: ACTIB

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

PEANUT OIL

Code: 5TL50QU0W4

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

Active Moieties

PROGESTERONE

Code: 4G7DS2Q64Y

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