diclofenac sodium dr

Generic: diclofenac sodium

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

Drug Facts

Product Profile

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

diclofenac sodium 50 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0197
Product ID 80425-0197_2a99aae5-c907-7940-e063-6294a90a4146
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075185
Listing Expiration 2026-12-31
Marketing Start 2022-10-27

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 804250197
Hyphenated Format 80425-0197

Supplemental Identifiers

RxCUI
855906
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 sodium dr (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA075185 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-2)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-3)
source: ndc

Packages (2)

80425-0197-2 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-2) 80425-0197-3 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-3)

Ingredients (1)

diclofenac sodium (50 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium DR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99aae5-c907-7940-e063-6294a90a4146", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855906"], "spl_set_id": ["ec06cca5-3436-10c8-e053-2995a90a4aeb"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-2)", "package_ndc": "80425-0197-2", "marketing_start_date": "20231027"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-3)", "package_ndc": "80425-0197-3", "marketing_start_date": "20231027"}], "brand_name": "Diclofenac Sodium DR", "product_id": "80425-0197_2a99aae5-c907-7940-e063-6294a90a4146", "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": "80425-0197", "generic_name": "Diclofenac Sodium", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "brand_name_suffix": "DR", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA075185", "marketing_category": "ANDA", "marketing_start_date": "20221027", "listing_expiration_date": "20261231"}