misoprostol

Generic: misoprostol

Labeler: genbiopro, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler genbiopro, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 200 ug/1

Manufacturer
GenBioPro, Inc.

Identifiers & Regulatory

Product NDC 43393-200
Product ID 43393-200_2d6ce914-5f86-a393-e063-6294a90a6d9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210201
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

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 43393200
Hyphenated Format 43393-200

Supplemental Identifiers

RxCUI
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 ANDA210201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (43393-200-48) / 4 TABLET in 1 BLISTER PACK (43393-200-04)
  • 60 TABLET in 1 BOTTLE (43393-200-60)
source: ndc

Packages (2)

43393-200-48 12 BLISTER PACK in 1 CARTON (43393-200-48) / 4 TABLET in 1 BLISTER PACK (43393-200-04) 43393-200-60 60 TABLET in 1 BOTTLE (43393-200-60)

Ingredients (1)

misoprostol (200 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": "2d6ce914-5f86-a393-e063-6294a90a6d9a", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["317128"], "spl_set_id": ["21e20753-4a67-ce4e-e063-6394a90aa598"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["GenBioPro, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (43393-200-48)  / 4 TABLET in 1 BLISTER PACK (43393-200-04)", "package_ndc": "43393-200-48", "marketing_start_date": "20240930"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43393-200-60)", "package_ndc": "43393-200-60", "marketing_start_date": "20240930"}], "brand_name": "Misoprostol", "product_id": "43393-200_2d6ce914-5f86-a393-e063-6294a90a6d9a", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "43393-200", "generic_name": "Misoprostol", "labeler_name": "GenBioPro, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA210201", "marketing_category": "ANDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}