PROGESTERONE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 119723554

Effective Date

October 5, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Progesterone(50 mg in 1 mL)

Products1

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

NDC Product Code

0591-3128

Application Number

NDA017362

Marketing Category

NDA (C73594)

Route of Administration

INTRAMUSCULAR

Effective Date

October 5, 2022

Ingredients

Code: 4G7DS2Q64YClass: ACTIBQuantity: 50 mg in 1 mL

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

SESAME OILInactive

Code: QX10HYY4QVClass: IACT