cytotec

Generic: misoprostol

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cytotec
Generic Name misoprostol
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 200 ug/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0025-1461
Product ID 0025-1461_253d5240-18d7-4f06-8314-a5632648cd47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019268
Listing Expiration 2026-12-31
Marketing Start 1986-12-27

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 00251461
Hyphenated Format 0025-1461

Supplemental Identifiers

RxCUI
104098 209177 311727 317128
UPC
0300251461606
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 cytotec (source: ndc)
Generic Name misoprostol (source: ndc)
Application Number NDA019268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31)
  • 60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60)
source: ndc

Packages (2)

0025-1461-31 100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31) 0025-1461-60 60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60)

Ingredients (1)

misoprostol (200 ug/1)

Linked Drug Pages (1)

Cytotec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "253d5240-18d7-4f06-8314-a5632648cd47", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0300251461606"], "unii": ["0E43V0BB57"], "rxcui": ["104098", "209177", "311727", "317128"], "spl_set_id": ["4ab12da7-5731-4e06-bf1c-bc3f2e711f12"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31)", "package_ndc": "0025-1461-31", "marketing_start_date": "19861227"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60)", "package_ndc": "0025-1461-60", "marketing_start_date": "19861227"}], "brand_name": "Cytotec", "product_id": "0025-1461_253d5240-18d7-4f06-8314-a5632648cd47", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "0025-1461", "generic_name": "misoprostol", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cytotec", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "NDA019268", "marketing_category": "NDA", "marketing_start_date": "19861227", "listing_expiration_date": "20261231"}