diclofenac sodium

Generic: diclofenac sodium topical

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical
Labeler preferred pharmaceuticals inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 30 mg/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8456
Product ID 68788-8456_d71d9769-402d-424b-9d2b-6ae24bab24e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212351
Listing Expiration 2026-12-31
Marketing Start 2023-06-08

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 687888456
Hyphenated Format 68788-8456

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
  • 1 TUBE in 1 CARTON (68788-8456-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

68788-8456-1 1 TUBE in 1 CARTON (68788-8456-1) / 100 g in 1 TUBE

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": "d71d9769-402d-424b-9d2b-6ae24bab24e2", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["6d5243ae-4a1a-4583-9337-085520e1f14a"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-8456-1)  / 100 g in 1 TUBE", "package_ndc": "68788-8456-1", "marketing_start_date": "20230608"}], "brand_name": "Diclofenac Sodium", "product_id": "68788-8456_d71d9769-402d-424b-9d2b-6ae24bab24e2", "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": "68788-8456", "generic_name": "Diclofenac Sodium Topical", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20230608", "listing_expiration_date": "20261231"}