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 TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-572
Product ID 76420-572_130b5bc8-64da-8224-e063-6294a90a1d8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090066
Listing Expiration 2026-12-31
Marketing Start 2010-12-31

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 76420572
Hyphenated Format 76420-572

Supplemental Identifiers

RxCUI
855664 855906 855926
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 ANDA090066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-01)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-60)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-90)
source: ndc

Packages (4)

76420-572-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-01) 76420-572-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-30) 76420-572-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-60) 76420-572-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-90)

Ingredients (1)

diclofenac sodium (50 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "130b5bc8-64da-8224-e063-6294a90a1d8e", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855664", "855906", "855926"], "spl_set_id": ["2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-01)", "package_ndc": "76420-572-01", "marketing_start_date": "20240307"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-30)", "package_ndc": "76420-572-30", "marketing_start_date": "20240307"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-60)", "package_ndc": "76420-572-60", "marketing_start_date": "20240307"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-90)", "package_ndc": "76420-572-90", "marketing_start_date": "20240307"}], "brand_name": "Diclofenac Sodium", "product_id": "76420-572_130b5bc8-64da-8224-e063-6294a90a1d8e", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-572", "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": "50 mg/1"}], "application_number": "ANDA090066", "marketing_category": "ANDA", "marketing_start_date": "20101231", "listing_expiration_date": "20261231"}