diclofenac sodium

Generic: diclofenac sodium topical

Labeler: medsource pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical
Labeler medsource pharmaceuticals
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 30 mg/g

Manufacturer
Medsource Pharmaceuticals

Identifiers & Regulatory

Product NDC 45865-260
Product ID 45865-260_1495ed53-048a-a465-e063-6394a90af68d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212351
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

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 45865260
Hyphenated Format 45865-260

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 (source: ndc)
Generic Name diclofenac sodium topical (source: ndc)
Application Number ANDA212351 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 100 g in 1 TUBE (45865-260-01)
source: ndc

Packages (1)

45865-260-01 100 g in 1 TUBE (45865-260-01)

Ingredients (1)

diclofenac sodium (30 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": "1495ed53-048a-a465-e063-6394a90af68d", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["1495ed53-0489-a465-e063-6394a90af68d"], "manufacturer_name": ["Medsource Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 g in 1 TUBE (45865-260-01)", "package_ndc": "45865-260-01", "marketing_start_date": "20230707"}], "brand_name": "Diclofenac Sodium", "product_id": "45865-260_1495ed53-048a-a465-e063-6394a90af68d", "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": "45865-260", "generic_name": "Diclofenac Sodium Topical", "labeler_name": "Medsource Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA212351", "marketing_category": "ANDA", "marketing_start_date": "20220915", "listing_expiration_date": "20261231"}