diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

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

diclofenac sodium 10 mg/g

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0233
Product ID 80425-0233_2a9b7c00-167d-4da0-e063-6394a90a926d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2026-12-31
Marketing Start 2023-02-06

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 804250233
Hyphenated Format 80425-0233

Supplemental Identifiers

RxCUI
855633
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 ANDA210986 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80425-0233-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

80425-0233-1 1 TUBE in 1 CARTON (80425-0233-1) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 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": "2a9b7c00-167d-4da0-e063-6394a90a926d", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["f3d27ae6-1259-5375-e053-2995a90a572d"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80425-0233-1)  / 100 g in 1 TUBE", "package_ndc": "80425-0233-1", "marketing_start_date": "20230206"}], "brand_name": "Diclofenac Sodium", "product_id": "80425-0233_2a9b7c00-167d-4da0-e063-6394a90a926d", "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": "80425-0233", "generic_name": "Diclofenac Sodium", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA210986", "marketing_category": "ANDA", "marketing_start_date": "20230206", "listing_expiration_date": "20261231"}