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FDA Approval

Misoprostol

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

FDA Approval Summary

Company
Effective Date
February 17, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Misoprostol(200 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

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

Misoprostol

Product Details

NDC Product Code
68071-4843
Application Number
ANDA091667
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 17, 2021
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
Code: 0E43V0BB57Class: ACTIBQuantity: 200 ug in 1 1
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