diclofenac sodium

Generic: diclofenac sodium

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-953
Product ID 45802-953_2672b394-97f0-4839-add5-176504b9de00
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211253
Listing Expiration 2026-12-31
Marketing Start 2020-07-09

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 45802953
Hyphenated Format 45802-953

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 sodium (source: ndc)
Application Number ANDA211253 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-953-01) / 100 g in 1 TUBE
source: ndc

Packages (1)

45802-953-01 1 TUBE in 1 CARTON (45802-953-01) / 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": "2672b394-97f0-4839-add5-176504b9de00", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["17bd62a8-b697-48cc-b988-aac3c19c6dc5"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-953-01)  / 100 g in 1 TUBE", "package_ndc": "45802-953-01", "marketing_start_date": "20200709"}], "brand_name": "Diclofenac Sodium", "product_id": "45802-953_2672b394-97f0-4839-add5-176504b9de00", "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": "45802-953", "generic_name": "diclofenac sodium", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA211253", "marketing_category": "ANDA", "marketing_start_date": "20200709", "listing_expiration_date": "20261231"}