MedPath

Progesterone

Progesterone Capsules

Approved
Approval ID

e210081e-8405-5b3d-e053-2a95a90aab9d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 15, 2023

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-2768
Application NumberANDA205229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (7)

PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PROGESTERONEActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB

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Progesterone - FDA Drug Approval Details