diclofenac sodium 1.5% (68788-8084)

Drug Facts

Product Profile

Brand Name diclofenac sodium 1.5%

Generic Name diclofenac sodium topical

Labeler preferred pharmaceuticals inc.

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer

Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8084

Product ID 68788-8084_51b4bcee-b586-4476-8ce8-898537958b66

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204132

Listing Expiration 2026-12-31

Marketing Start 2021-10-05

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 687888084

Hyphenated Format 68788-8084

Supplemental Identifiers

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 1.5% (source: ndc)

Generic Name diclofenac sodium topical (source: ndc)

Application Number ANDA204132 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

16.05 mg/mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING 16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac Sodium Topical Solution USP, 1.5% w/w is supplied as a clear, colorless to faintly pink orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low density polyethylene dropper cap. NDC Number and Size 5 FL.OZ. (150 mL) bottle in cartons of one NDC # 68788-8084-1 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].
Diclofenac Sodium Topical Solution 1.5% ww

source: label

Packages (0)

No package records.

Ingredients (1)

diclofenac sodium (16.05 mg/mL)

Linked Drug Pages (1)

Diclofenac Sodium 1.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "51b4bcee-b586-4476-8ce8-898537958b66", "openfda": {"unii": ["QTG126297Q"], "spl_set_id": ["dbcd42cf-d44a-4d47-9149-66ffcf9a0587"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [], "brand_name": "Diclofenac Sodium 1.5%", "product_id": "68788-8084_51b4bcee-b586-4476-8ce8-898537958b66", "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": "68788-8084", "generic_name": "Diclofenac Sodium Topical", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium 1.5%", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA204132", "marketing_category": "ANDA", "marketing_start_date": "20211005", "listing_expiration_date": "20261231"}