diclofenac sodium

Generic: diclofenac sodium

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler aurohealth llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-604
Product ID 58602-604_aa7e21b9-c07f-48a6-9266-67a490fd2b8b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204306
Listing Expiration 2026-12-31
Marketing Start 2023-05-10

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 58602604
Hyphenated Format 58602-604

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 ANDA204306 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (58602-604-07) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (58602-604-18) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (58602-604-19) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (58602-604-20) / 150 g in 1 TUBE
  • 3 TUBE in 1 CARTON (58602-604-22) / 150 g in 1 TUBE
  • 2 TUBE in 1 CARTON (58602-604-23) / 100 g in 1 TUBE
source: ndc

Packages (6)

58602-604-07 1 TUBE in 1 CARTON (58602-604-07) / 100 g in 1 TUBE 58602-604-18 1 TUBE in 1 CARTON (58602-604-18) / 20 g in 1 TUBE 58602-604-19 1 TUBE in 1 CARTON (58602-604-19) / 50 g in 1 TUBE 58602-604-20 1 TUBE in 1 CARTON (58602-604-20) / 150 g in 1 TUBE 58602-604-22 3 TUBE in 1 CARTON (58602-604-22) / 150 g in 1 TUBE 58602-604-23 2 TUBE in 1 CARTON (58602-604-23) / 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": "aa7e21b9-c07f-48a6-9266-67a490fd2b8b", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["81e964ff-6622-4054-bf01-6ed6eef6778f"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (58602-604-07)  / 100 g in 1 TUBE", "package_ndc": "58602-604-07", "marketing_start_date": "20230510"}, {"sample": false, "description": "1 TUBE in 1 CARTON (58602-604-18)  / 20 g in 1 TUBE", "package_ndc": "58602-604-18", "marketing_start_date": "20230510"}, {"sample": false, "description": "1 TUBE in 1 CARTON (58602-604-19)  / 50 g in 1 TUBE", "package_ndc": "58602-604-19", "marketing_start_date": "20230510"}, {"sample": false, "description": "1 TUBE in 1 CARTON (58602-604-20)  / 150 g in 1 TUBE", "package_ndc": "58602-604-20", "marketing_start_date": "20230510"}, {"sample": false, "description": "3 TUBE in 1 CARTON (58602-604-22)  / 150 g in 1 TUBE", "package_ndc": "58602-604-22", "marketing_start_date": "20230510"}, {"sample": false, "description": "2 TUBE in 1 CARTON (58602-604-23)  / 100 g in 1 TUBE", "package_ndc": "58602-604-23", "marketing_start_date": "20230510"}], "brand_name": "Diclofenac Sodium", "product_id": "58602-604_aa7e21b9-c07f-48a6-9266-67a490fd2b8b", "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": "58602-604", "generic_name": "Diclofenac Sodium", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA204306", "marketing_category": "ANDA", "marketing_start_date": "20230510", "listing_expiration_date": "20261231"}