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/ DROPS
Routes
TRANSDERMAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-134
Product ID 76420-134_b965985a-9568-58f3-e053-2995a90a008c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204132
Listing Expiration 2026-12-31
Marketing Start 2015-08-20

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 76420134
Hyphenated Format 76420-134

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 ANDA204132 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE (76420-134-05)
source: ndc

Packages (1)

76420-134-05 150 mL in 1 BOTTLE (76420-134-05)

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": ["TRANSDERMAL"], "spl_id": "b965985a-9568-58f3-e053-2995a90a008c", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (76420-134-05)", "package_ndc": "76420-134-05", "marketing_start_date": "20210121"}], "brand_name": "Diclofenac Sodium", "product_id": "76420-134_b965985a-9568-58f3-e053-2995a90a008c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-134", "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": "ANDA204132", "marketing_category": "ANDA", "marketing_start_date": "20150820", "listing_expiration_date": "20261231"}