diclofenac sodium

Generic: diclofenac

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac
Labeler amneal pharmaceuticals ny llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2053
Product ID 69238-2053_a723bc13-8e04-48e5-8427-5cb5e6471e4a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208077
Listing Expiration 2026-12-31
Marketing Start 2016-03-21

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 692382053
Hyphenated Format 69238-2053

Supplemental Identifiers

RxCUI
855633
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 (source: ndc)
Application Number ANDA208077 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69238-2053-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

69238-2053-1 1 TUBE in 1 CARTON (69238-2053-1) / 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": "a723bc13-8e04-48e5-8427-5cb5e6471e4a", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["1084e0c3-6d75-4090-84dc-02a18e0299b9"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69238-2053-1)  / 100 g in 1 TUBE", "package_ndc": "69238-2053-1", "marketing_start_date": "20160321"}], "brand_name": "Diclofenac sodium", "product_id": "69238-2053_a723bc13-8e04-48e5-8427-5cb5e6471e4a", "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": "69238-2053", "generic_name": "Diclofenac", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA208077", "marketing_category": "ANDA", "marketing_start_date": "20160321", "listing_expiration_date": "20261231"}