diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

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

diclofenac sodium 20 mg/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-074
Product ID 82804-074_f104f8fb-066f-4bbf-8894-3b3ed1b8266d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213040
Listing Expiration 2026-12-31
Marketing Start 2023-02-03

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 82804074
Hyphenated Format 82804-074

Supplemental Identifiers

RxCUI
1487074
UPC
0382804074129
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 ANDA213040 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (82804-074-12) / 112 g in 1 BOTTLE
source: ndc

Packages (1)

82804-074-12 1 BOTTLE in 1 CARTON (82804-074-12) / 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": "f104f8fb-066f-4bbf-8894-3b3ed1b8266d", "openfda": {"upc": ["0382804074129"], "unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["f104f8fb-066f-4bbf-8894-3b3ed1b8266d"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82804-074-12)  / 112 g in 1 BOTTLE", "package_ndc": "82804-074-12", "marketing_start_date": "20240325"}], "brand_name": "Diclofenac Sodium", "product_id": "82804-074_f104f8fb-066f-4bbf-8894-3b3ed1b8266d", "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": "82804-074", "generic_name": "Diclofenac Sodium", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA213040", "marketing_category": "ANDA", "marketing_start_date": "20230203", "listing_expiration_date": "20261231"}