diclofenac sodium

Generic: diclofenac sodium topical gel, 1%,

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 gel, 1%,
Labeler preferred pharmaceuticals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7772
Product ID 68788-7772_f86c3fa2-c940-4d96-9468-d4966d4aad20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2026-12-31
Marketing Start 2020-08-03

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 687887772
Hyphenated Format 68788-7772

Supplemental Identifiers

RxCUI
855633
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 gel, 1%, (source: ndc)
Application Number ANDA210986 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68788-7772-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

68788-7772-1 1 TUBE in 1 CARTON (68788-7772-1) / 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": "f86c3fa2-c940-4d96-9468-d4966d4aad20", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["aee20924-79ab-400e-b9b6-418978914654"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-7772-1)  / 100 g in 1 TUBE", "package_ndc": "68788-7772-1", "marketing_start_date": "20200803"}], "brand_name": "Diclofenac Sodium", "product_id": "68788-7772_f86c3fa2-c940-4d96-9468-d4966d4aad20", "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": "68788-7772", "generic_name": "Diclofenac Sodium Topical Gel, 1%,", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA210986", "marketing_category": "ANDA", "marketing_start_date": "20200803", "listing_expiration_date": "20261231"}