diclofenac sodium

Generic: diclofenac sodium topical gel, 1%

Labeler: simple diagnostics
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical gel, 1%
Labeler simple diagnostics
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Simple Diagnostics

Identifiers & Regulatory

Product NDC 62379-401
Product ID 62379-401_14062028-4023-9b1c-e063-6394a90a1f53
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2026-12-31
Marketing Start 2024-03-13

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 62379401
Hyphenated Format 62379-401

Supplemental Identifiers

RxCUI
855633
UPC
0850002860658 0850002860665
UNII
QTG126297Q

Packaging Origin

Original Packager
true

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 gel, 1% (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 (62379-401-02) / 100 g in 1 TUBE (62379-401-01)
  • 1 TUBE in 1 CARTON (62379-401-04) / 150 g in 1 TUBE (62379-401-03)
source: ndc

Packages (2)

62379-401-02 1 TUBE in 1 CARTON (62379-401-02) / 100 g in 1 TUBE (62379-401-01) 62379-401-04 1 TUBE in 1 CARTON (62379-401-04) / 150 g in 1 TUBE (62379-401-03)

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": "14062028-4023-9b1c-e063-6394a90a1f53", "openfda": {"upc": ["0850002860658", "0850002860665"], "unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["13925cd5-e121-80d2-e063-6394a90af9a9"], "manufacturer_name": ["Simple Diagnostics"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (62379-401-02)  / 100 g in 1 TUBE (62379-401-01)", "package_ndc": "62379-401-02", "marketing_start_date": "20240313"}, {"sample": false, "description": "1 TUBE in 1 CARTON (62379-401-04)  / 150 g in 1 TUBE (62379-401-03)", "package_ndc": "62379-401-04", "marketing_start_date": "20240313"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "62379-401_14062028-4023-9b1c-e063-6394a90a1f53", "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": "62379-401", "generic_name": "diclofenac sodium topical gel, 1%", "labeler_name": "Simple Diagnostics", "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": "20240313", "listing_expiration_date": "20261231"}