Misoprostol

Misoprostol Tablets Rx only

Approved

Approval ID

02074b64-64ff-115c-e063-6294a90a8d0b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 13, 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.

NDC Product Code68071-3458

Application NumberANDA076095

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 13, 2023

Generic NameMisoprostol

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EA

Classification: IACT

MISOPROSTOLActive

Quantity: 200 ug in 1 1

Code: 0E43V0BB57

Classification: ACTIB