diclofenac sodium

Generic: diclofenac sodium topical

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

Drug Facts

Product Profile

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

diclofenac sodium 30 mg/g

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0338
Product ID 80425-0338_2a9ba8f4-6cf2-e827-e063-6394a90a0300
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212351
Listing Expiration 2026-12-31
Marketing Start 2023-05-19

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 804250338
Hyphenated Format 80425-0338

Supplemental Identifiers

RxCUI
855642
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 topical (source: ndc)
Application Number ANDA212351 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80425-0338-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

80425-0338-1 1 TUBE in 1 CARTON (80425-0338-1) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (30 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": "2a9ba8f4-6cf2-e827-e063-6394a90a0300", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["fc0e6a51-bec3-f7ee-e053-6394a90ada9a"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80425-0338-1)  / 100 g in 1 TUBE", "package_ndc": "80425-0338-1", "marketing_start_date": "20230519"}], "brand_name": "Diclofenac Sodium", "product_id": "80425-0338_2a9ba8f4-6cf2-e827-e063-6394a90a0300", "dosage_form": "GEL", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0338", "generic_name": "Diclofenac Sodium Topical", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA212351", "marketing_category": "ANDA", "marketing_start_date": "20230519", "listing_expiration_date": "20261231"}