dicloenac sodium and misoprostol dr

Generic: dicloenac sodium and misoprostol

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

Drug Facts

Product Profile

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

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

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0273
Product ID 80425-0273_12141491-25f0-fbc5-e063-6394a90a1f23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204355
Listing Expiration 2026-12-31
Marketing Start 2023-02-16

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 804250273
Hyphenated Format 80425-0273

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 dicloenac sodium and misoprostol dr (source: ndc)
Generic Name dicloenac sodium and misoprostol (source: ndc)
Application Number ANDA204355 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (80425-0273-1)
source: ndc

Packages (1)

80425-0273-1 60 TABLET in 1 BOTTLE (80425-0273-1)

Ingredients (2)

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

Linked Drug Pages (1)

DICLOENAC SODIUM and MISOPROSTOL DR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12141491-25f0-fbc5-e063-6394a90a1f23", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["1359105"], "spl_set_id": ["f4d8c198-63e1-3109-e053-2995a90acad9"], "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 in 1 BOTTLE (80425-0273-1)", "package_ndc": "80425-0273-1", "marketing_start_date": "20230216"}], "brand_name": "DICLOENAC SODIUM and MISOPROSTOL DR", "product_id": "80425-0273_12141491-25f0-fbc5-e063-6394a90a1f23", "dosage_form": "TABLET", "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": "80425-0273", "generic_name": "DICLOENAC SODIUM and MISOPROSTOL", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLOENAC SODIUM and MISOPROSTOL", "brand_name_suffix": "DR", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA204355", "marketing_category": "ANDA", "marketing_start_date": "20230216", "listing_expiration_date": "20261231"}