diclofenac sodium

Generic: diclofenac sodium topical

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical
Labeler proficient rx lp
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 30 mg/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-250
Product ID 82804-250_9f1af144-5910-4484-ba6e-6c87e0efba45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212351
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

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 82804250
Hyphenated Format 82804-250

Supplemental Identifiers

RxCUI
855642
UPC
0382804250004
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 (82804-250-00) / 100 g in 1 TUBE
source: ndc

Packages (1)

82804-250-00 1 TUBE in 1 CARTON (82804-250-00) / 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": "9f1af144-5910-4484-ba6e-6c87e0efba45", "openfda": {"upc": ["0382804250004"], "unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["140a2c64-4996-4da3-b10f-1b8235ebde9d"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (82804-250-00)  / 100 g in 1 TUBE", "package_ndc": "82804-250-00", "marketing_start_date": "20251023"}], "brand_name": "Diclofenac Sodium", "product_id": "82804-250_9f1af144-5910-4484-ba6e-6c87e0efba45", "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": "82804-250", "generic_name": "Diclofenac Sodium Topical", "labeler_name": "Proficient Rx LP", "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": "20220915", "listing_expiration_date": "20261231"}