diclofenac sodium

Generic: diclofenac

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

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac
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 76420-012
Product ID 76420-012_ead0dde9-f4f4-9f9b-e053-2a95a90ac6e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206116
Listing Expiration 2026-12-31
Marketing Start 2016-09-02

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 76420012
Hyphenated Format 76420-012

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 (source: ndc)
Application Number ANDA206116 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE (76420-012-30)
source: ndc

Packages (1)

76420-012-30 150 mL in 1 BOTTLE (76420-012-30)

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": "ead0dde9-f4f4-9f9b-e053-2a95a90ac6e5", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["9df599de-6412-a94e-e053-2995a90a1741"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (76420-012-30)", "package_ndc": "76420-012-30", "marketing_start_date": "20200205"}], "brand_name": "Diclofenac Sodium", "product_id": "76420-012_ead0dde9-f4f4-9f9b-e053-2a95a90ac6e5", "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": "76420-012", "generic_name": "Diclofenac", "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": "ANDA206116", "marketing_category": "ANDA", "marketing_start_date": "20160902", "listing_expiration_date": "20261231"}