diclofenac sodium

Generic: diclofenac sodium

Labeler: exelan pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 10 mg/g

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-103
Product ID 76282-103_6fc74e92-7f37-41e7-aa8b-8fd0275a57c9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209903
Listing Expiration 2026-12-31
Marketing Start 2024-07-30

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 76282103
Hyphenated Format 76282-103

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 ANDA209903 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (76282-103-39) / 100 g in 1 TUBE
source: ndc

Packages (1)

76282-103-39 1 TUBE in 1 CARTON (76282-103-39) / 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": "6fc74e92-7f37-41e7-aa8b-8fd0275a57c9", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["be25c19e-cbea-4f87-a581-9f0d350e5adf"], "manufacturer_name": ["EXELAN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76282-103-39)  / 100 g in 1 TUBE", "package_ndc": "76282-103-39", "marketing_start_date": "20240730"}], "brand_name": "Diclofenac Sodium", "product_id": "76282-103_6fc74e92-7f37-41e7-aa8b-8fd0275a57c9", "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": "76282-103", "generic_name": "Diclofenac sodium", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA209903", "marketing_category": "ANDA", "marketing_start_date": "20240730", "listing_expiration_date": "20261231"}