diclofenac dr

Generic: diclofenac

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

Drug Facts

Product Profile

Brand Name diclofenac dr
Generic Name diclofenac
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0056
Product ID 80425-0056_2a98d0b7-639a-da12-e063-6294a90a2a7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077863
Listing Expiration 2026-12-31
Marketing Start 2008-08-19

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] decreased prostaglandin production [pe] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250056
Hyphenated Format 80425-0056

Supplemental Identifiers

RxCUI
855926
UNII
QTG126297Q

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 dr (source: ndc)
Generic Name diclofenac (source: ndc)
Application Number ANDA077863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0056-1)
source: ndc

Packages (1)

80425-0056-1 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0056-1)

Ingredients (1)

diclofenac sodium (75 mg/1)

Linked Drug Pages (1)

Diclofenac DR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a98d0b7-639a-da12-e063-6294a90a2a7e", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["af8a30fb-ead8-7e29-e053-2a95a90a040f"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0056-1)", "package_ndc": "80425-0056-1", "marketing_start_date": "20080819"}], "brand_name": "Diclofenac DR", "product_id": "80425-0056_2a98d0b7-639a-da12-e063-6294a90a2a7e", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0056", "generic_name": "Diclofenac", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac", "brand_name_suffix": "DR", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA077863", "marketing_category": "ANDA", "marketing_start_date": "20080819", "listing_expiration_date": "20261231"}