arthrotec

Generic: diclofenac sodium and misoprostol

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

Drug Facts

Product Profile

Brand Name arthrotec
Generic Name diclofenac sodium and misoprostol
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1, misoprostol 200 ug/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0025-1421
Product ID 0025-1421_2b1bf1d7-4399-46bd-8654-2590513da5c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020607
Listing Expiration 2026-12-31
Marketing Start 1997-12-24

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 00251421
Hyphenated Format 0025-1421

Supplemental Identifiers

RxCUI
857706 1359105 1359107 1359109
UPC
0300251411601 0300251421600
UNII
QTG126297Q 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 arthrotec (source: ndc)
Generic Name diclofenac sodium and misoprostol (source: ndc)
Application Number NDA020607 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0025-1421-60)
source: ndc

Packages (1)

0025-1421-60 60 TABLET, FILM COATED in 1 BOTTLE (0025-1421-60)

Ingredients (2)

diclofenac sodium (75 mg/1) misoprostol (200 ug/1)

Linked Drug Pages (1)

ARTHROTEC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b1bf1d7-4399-46bd-8654-2590513da5c2", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0300251411601", "0300251421600"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105", "1359107", "1359109"], "spl_set_id": ["600fe842-45d9-4d68-9ef2-456dbbebaa11"], "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": "60 TABLET, FILM COATED in 1 BOTTLE (0025-1421-60)", "package_ndc": "0025-1421-60", "marketing_start_date": "19971224"}], "brand_name": "ARTHROTEC", "product_id": "0025-1421_2b1bf1d7-4399-46bd-8654-2590513da5c2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "0025-1421", "generic_name": "diclofenac sodium and misoprostol", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARTHROTEC", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "NDA020607", "marketing_category": "NDA", "marketing_start_date": "19971224", "listing_expiration_date": "20261231"}