misoprostol

Generic: misoprostol

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 100 ug/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-735
Product ID 60687-735_253ebbef-3f86-8958-e063-6394a90ad713
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076095
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

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 60687735
Hyphenated Format 60687-735

Supplemental Identifiers

RxCUI
311727 317128
UNII
0E43V0BB57
NUI
N0000175785 M0017811

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 ANDA076095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 ug/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-735-01) / 1 TABLET in 1 BLISTER PACK (60687-735-11)
source: ndc

Packages (1)

60687-735-01 100 BLISTER PACK in 1 CARTON (60687-735-01) / 1 TABLET in 1 BLISTER PACK (60687-735-11)

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": "253ebbef-3f86-8958-e063-6394a90ad713", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["311727", "317128"], "spl_set_id": ["9462d969-d3e5-4e7f-b556-bd647ab28c42"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-735-01)  / 1 TABLET in 1 BLISTER PACK (60687-735-11)", "package_ndc": "60687-735-01", "marketing_start_date": "20230401"}], "brand_name": "Misoprostol", "product_id": "60687-735_253ebbef-3f86-8958-e063-6394a90ad713", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "60687-735", "generic_name": "Misoprostol", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "100 ug/1"}], "application_number": "ANDA076095", "marketing_category": "ANDA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}