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 82804-113
Product ID 82804-113_898558e7-17f8-40cd-9dfc-67ddd64a5a42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208021
Listing Expiration 2026-12-31
Marketing Start 2024-02-19

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 82804113
Hyphenated Format 82804-113

Supplemental Identifiers

RxCUI
1487074
UPC
0382804113125
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 ANDA208021 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (82804-113-12) / 112 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

82804-113-12 1 BOTTLE, PUMP in 1 CARTON (82804-113-12) / 112 g in 1 BOTTLE, PUMP

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": "898558e7-17f8-40cd-9dfc-67ddd64a5a42", "openfda": {"upc": ["0382804113125"], "unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["898558e7-17f8-40cd-9dfc-67ddd64a5a42"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (82804-113-12)  / 112 g in 1 BOTTLE, PUMP", "package_ndc": "82804-113-12", "marketing_start_date": "20240705"}], "brand_name": "Diclofenac Sodium", "product_id": "82804-113_898558e7-17f8-40cd-9dfc-67ddd64a5a42", "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": "82804-113", "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": "ANDA208021", "marketing_category": "ANDA", "marketing_start_date": "20240219", "listing_expiration_date": "20261231"}