diclofenac sodium

Generic: diclofenac sodium topical gel, 1%

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical gel, 1%
Labeler bluepoint laboratories
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-621
Product ID 68001-621_3c186ca4-daa6-7e58-e063-6294a90a3518
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2026-12-31
Marketing Start 2025-05-17

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 68001621
Hyphenated Format 68001-621

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 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 (68001-621-45) / 100 g in 1 TUBE
source: ndc

Packages (1)

68001-621-45 1 TUBE in 1 CARTON (68001-621-45) / 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": "3c186ca4-daa6-7e58-e063-6294a90a3518", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["274543d2-a9a6-1e37-e063-6394a90ae3f1"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68001-621-45)  / 100 g in 1 TUBE", "package_ndc": "68001-621-45", "marketing_start_date": "20250517"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "68001-621_3c186ca4-daa6-7e58-e063-6294a90a3518", "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": "68001-621", "generic_name": "Diclofenac Sodium Topical Gel, 1%", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA210986", "marketing_category": "ANDA", "marketing_start_date": "20250517", "listing_expiration_date": "20261231"}