MedPath

PROGESTERONE

Revised: September 2014

Approved
Approval ID

a09a3b76-36f1-4d20-930e-7e3da97e7ebd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2022

Manufacturers
FDA

Actavis Pharma, Inc.

DUNS: 119723554

Products 1

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

PROGESTERONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0591-3128
Application NumberNDA017362
Product Classification
M
Marketing Category
C73594
G
Generic Name
PROGESTERONE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateOctober 5, 2022
FDA Product Classification

INGREDIENTS (3)

PROGESTERONEActive
Quantity: 50 mg in 1 mL
Code: 4G7DS2Q64Y
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

PROGESTERONE - FDA Drug Approval Details