diclofenac sodium

Generic: diclofenac sodium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-919
Product ID 76420-919_2d9db307-1bf0-ed7f-e063-6294a90a0c53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203818
Listing Expiration 2026-12-31
Marketing Start 2014-11-26

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 76420919
Hyphenated Format 76420-919

Supplemental Identifiers

RxCUI
857700
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 (source: ndc)
Application Number ANDA203818 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (76420-919-02) / 150 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (76420-919-04) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

76420-919-02 1 BOTTLE, DROPPER in 1 CARTON (76420-919-02) / 150 mL in 1 BOTTLE, DROPPER 76420-919-04 1 BOTTLE, DROPPER in 1 CARTON (76420-919-04) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (1)

diclofenac sodium (16.05 mg/mL)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2d9db307-1bf0-ed7f-e063-6294a90a0c53", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["5508f80d-5f11-4959-8e42-9055f0169cfc"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (76420-919-02)  / 150 mL in 1 BOTTLE, DROPPER", "package_ndc": "76420-919-02", "marketing_start_date": "20250208"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (76420-919-04)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "76420-919-04", "marketing_start_date": "20250208"}], "brand_name": "Diclofenac Sodium", "product_id": "76420-919_2d9db307-1bf0-ed7f-e063-6294a90a0c53", "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": "76420-919", "generic_name": "Diclofenac Sodium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA203818", "marketing_category": "ANDA", "marketing_start_date": "20141126", "listing_expiration_date": "20261231"}