misoprostol

Generic: misoprostol

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 200 ug/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-254
Product ID 42571-254_35016de6-7e52-0209-e063-6394a90ade8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216872
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

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 42571254
Hyphenated Format 42571-254

Supplemental Identifiers

RxCUI
311727 317128
UPC
0342571253608 0342571254605
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 ANDA216872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42571-254-01)
  • 60 TABLET in 1 BOTTLE (42571-254-60)
source: ndc

Packages (2)

42571-254-01 100 TABLET in 1 BOTTLE (42571-254-01) 42571-254-60 60 TABLET in 1 BOTTLE (42571-254-60)

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": "35016de6-7e52-0209-e063-6394a90ade8e", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0342571253608", "0342571254605"], "unii": ["0E43V0BB57"], "rxcui": ["311727", "317128"], "spl_set_id": ["54d26ca3-d309-4048-8699-a04b3854ef9c"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42571-254-01)", "package_ndc": "42571-254-01", "marketing_start_date": "20230101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (42571-254-60)", "package_ndc": "42571-254-60", "marketing_start_date": "20230101"}], "brand_name": "MISOPROSTOL", "product_id": "42571-254_35016de6-7e52-0209-e063-6394a90ade8e", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "42571-254", "generic_name": "Misoprostol", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MISOPROSTOL", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA216872", "marketing_category": "ANDA", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}