misoprostol

Generic: misoprostol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 100 ug/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-5007
Product ID 59762-5007_064226ff-4bbc-45c3-93e0-2266ddffc2b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019268
Listing Expiration 2026-12-31
Marketing Start 2009-12-27

Pharmacologic Class

Established (EPC)
prostaglandin e1 analog [epc]
Chemical Structure
prostaglandins e, synthetic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597625007
Hyphenated Format 59762-5007

Supplemental Identifiers

RxCUI
311727 317128
UNII
0E43V0BB57
NUI
N0000175785 M0017811

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name misoprostol (source: ndc)
Generic Name misoprostol (source: ndc)
Application Number NDA019268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 ug/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (59762-5007-1)
  • 120 TABLET in 1 BOTTLE (59762-5007-2)
source: ndc

Packages (2)

59762-5007-1 60 TABLET in 1 BOTTLE (59762-5007-1) 59762-5007-2 120 TABLET in 1 BOTTLE (59762-5007-2)

Ingredients (1)

misoprostol (100 ug/1)

Linked Drug Pages (1)

misoprostol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "064226ff-4bbc-45c3-93e0-2266ddffc2b0", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["311727", "317128"], "spl_set_id": ["c4fe14fb-0a43-4c31-9cd6-29eb0d156705"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (59762-5007-1)", "package_ndc": "59762-5007-1", "marketing_start_date": "20091227"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (59762-5007-2)", "package_ndc": "59762-5007-2", "marketing_start_date": "20091227"}], "brand_name": "misoprostol", "product_id": "59762-5007_064226ff-4bbc-45c3-93e0-2266ddffc2b0", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "59762-5007", "generic_name": "MISOPROSTOL", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "100 ug/1"}], "application_number": "NDA019268", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20091227", "listing_expiration_date": "20261231"}