diclofenac sodium gel

Generic: diclofenac sodium gel

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium gel
Generic Name diclofenac sodium gel
Labeler direct_rx
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 30 mg/g

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-379
Product ID 72189-379_2c4ccc7d-5cb0-43b5-e063-6294a90a05ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208301
Listing Expiration 2026-12-31
Marketing Start 2022-09-08

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 72189379
Hyphenated Format 72189-379

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 gel (source: ndc)
Generic Name diclofenac sodium gel (source: ndc)
Application Number ANDA208301 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 1 g in 1 TUBE (72189-379-01)
source: ndc

Packages (1)

72189-379-01 1 g in 1 TUBE (72189-379-01)

Ingredients (1)

diclofenac sodium (30 mg/g)

Linked Drug Pages (1)

Diclofenac Sodium Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2c4ccc7d-5cb0-43b5-e063-6294a90a05ec", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["e82e4d34-bdaa-b950-e053-2995a90a29f1"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "1 g in 1 TUBE (72189-379-01)", "package_ndc": "72189-379-01", "marketing_start_date": "20220908"}], "brand_name": "Diclofenac Sodium Gel", "product_id": "72189-379_2c4ccc7d-5cb0-43b5-e063-6294a90a05ec", "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": "72189-379", "generic_name": "Diclofenac Sodium Gel", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium Gel", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA208301", "marketing_category": "ANDA", "marketing_start_date": "20220908", "listing_expiration_date": "20261231"}