misoprostol

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

Company

DUNS: 078364058

Effective Date

January 9, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Misoprostol(200 ug in 1 1)

Products1

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

NDC Product Code

43393-020

Application Number

NDA019268

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

January 9, 2024

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEYClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Code: 0E43V0BB57Class: ACTIBQuantity: 200 ug in 1 1