diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler advanced rx of tennessee, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0550
Product ID 80425-0550_3d71f78a-c28c-8488-e063-6294a90a14a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207714
Listing Expiration 2026-12-31
Marketing Start 2025-08-27

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 804250550
Hyphenated Format 80425-0550

Supplemental Identifiers

RxCUI
1487074
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 (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA207714 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (80425-0550-1) / 112 g in 1 BOTTLE
source: ndc

Packages (1)

80425-0550-1 1 BOTTLE in 1 CARTON (80425-0550-1) / 112 g in 1 BOTTLE

Ingredients (1)

diclofenac sodium (20 mg/g)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3d71f78a-c28c-8488-e063-6294a90a14a7", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["3d71f76d-bb23-7251-e063-6394a90aa9d8"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (80425-0550-1)  / 112 g in 1 BOTTLE", "package_ndc": "80425-0550-1", "marketing_start_date": "20250827"}], "brand_name": "Diclofenac Sodium", "product_id": "80425-0550_3d71f78a-c28c-8488-e063-6294a90a14a7", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0550", "generic_name": "Diclofenac Sodium", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA207714", "marketing_category": "ANDA", "marketing_start_date": "20250827", "listing_expiration_date": "20261231"}