misoprostol
Misoprostol Tablets
Approved
Approval ID
f15b41bd-ed36-4908-aba5-f0a019b7a26e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2017
Manufacturers
FDA
Apotheca Inc.
DUNS: 051457844
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MISOPROSTOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12634-502
Application NumberNDA019268
Product Classification
M
Marketing Category
C73605
G
Generic Name
MISOPROSTOL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2017
FDA Product Classification
INGREDIENTS (4)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB