diclofenac sodium and misoprostol dr

Generic: diclofenac sodium and misoprostol

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium and misoprostol dr
Generic Name diclofenac sodium and misoprostol
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0272
Product ID 80425-0272_1213898d-dffc-ce28-e063-6394a90a1a28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020607
Listing Expiration 2026-12-31
Marketing Start 2024-02-23

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 804250272
Hyphenated Format 80425-0272

Supplemental Identifiers

RxCUI
1359105
UNII
QTG126297Q 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 diclofenac sodium and misoprostol dr (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 (80425-0272-1)
source: ndc

Packages (1)

80425-0272-1 60 TABLET, FILM COATED in 1 BOTTLE (80425-0272-1)

Ingredients (2)

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

Linked Drug Pages (1)

Diclofenac sodium and Misoprostol DR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1213898d-dffc-ce28-e063-6394a90a1a28", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["1359105"], "spl_set_id": ["1213d3eb-9870-f144-e063-6394a90a6088"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0272-1)", "package_ndc": "80425-0272-1", "marketing_start_date": "20240223"}], "brand_name": "Diclofenac sodium and Misoprostol DR", "product_id": "80425-0272_1213898d-dffc-ce28-e063-6394a90a1a28", "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": "80425-0272", "generic_name": "Diclofenac sodium and Misoprostol", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac sodium and Misoprostol", "brand_name_suffix": "DR", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "NDA020607", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240223", "listing_expiration_date": "20261231"}