diclofenac sodium

Generic: diclofenac sodium

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler apotex corp.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0406
Product ID 60505-0406_623c9522-98af-c9da-47d6-a4b47f54efa2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207714
Listing Expiration 2026-12-31
Marketing Start 2022-05-09

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 605050406
Hyphenated Format 60505-0406

Supplemental Identifiers

RxCUI
1487074
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 ANDA207714 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (60505-0406-3) / 112 g in 1 BOTTLE
source: ndc

Packages (1)

60505-0406-3 1 BOTTLE in 1 CARTON (60505-0406-3) / 112 g in 1 BOTTLE

Ingredients (1)

diclofenac sodium (20 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": "623c9522-98af-c9da-47d6-a4b47f54efa2", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["9f416595-60b2-c921-5df4-a09d5f6abe71"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (60505-0406-3)  / 112 g in 1 BOTTLE", "package_ndc": "60505-0406-3", "marketing_start_date": "20220509"}], "brand_name": "Diclofenac Sodium", "product_id": "60505-0406_623c9522-98af-c9da-47d6-a4b47f54efa2", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60505-0406", "generic_name": "Diclofenac Sodium", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA207714", "marketing_category": "ANDA", "marketing_start_date": "20220509", "listing_expiration_date": "20261231"}