diclofenac potassium

Generic: diclofenac potassium tablets

Labeler: umedica laboratories usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium tablets
Labeler umedica laboratories usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac potassium 25 mg/1

Manufacturer
Umedica Laboratories USA Inc.

Identifiers & Regulatory

Product NDC 60290-088
Product ID 60290-088_4580535c-79b7-68b5-e063-6394a90a38a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215750
Listing Expiration 2026-12-31
Marketing Start 2022-05-12

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 60290088
Hyphenated Format 60290-088

Supplemental Identifiers

RxCUI
855942 857702
UPC
0360290088028 0360290088042 0360290088011 0360290057024
UNII
L4D5UA6CB4

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 potassium (source: ndc)
Generic Name diclofenac potassium tablets (source: ndc)
Application Number ANDA215750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60290-088-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE (60290-088-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE (60290-088-03)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (60290-088-04)
  • 60 TABLET, FILM COATED in 1 BOTTLE (60290-088-05)
source: ndc

Packages (5)

60290-088-01 30 TABLET, FILM COATED in 1 BOTTLE (60290-088-01) 60290-088-02 100 TABLET, FILM COATED in 1 BOTTLE (60290-088-02) 60290-088-03 500 TABLET, FILM COATED in 1 BOTTLE (60290-088-03) 60290-088-04 1000 TABLET, FILM COATED in 1 BOTTLE (60290-088-04) 60290-088-05 60 TABLET, FILM COATED in 1 BOTTLE (60290-088-05)

Ingredients (1)

diclofenac potassium (25 mg/1)

Linked Drug Pages (1)

Diclofenac Potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4580535c-79b7-68b5-e063-6394a90a38a9", "openfda": {"upc": ["0360290088028", "0360290088042", "0360290088011", "0360290057024"], "unii": ["L4D5UA6CB4"], "rxcui": ["855942", "857702"], "spl_set_id": ["1fa07fbe-3708-4200-b3ff-a920434896b6"], "manufacturer_name": ["Umedica Laboratories USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60290-088-01)", "package_ndc": "60290-088-01", "marketing_start_date": "20240928"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (60290-088-02)", "package_ndc": "60290-088-02", "marketing_start_date": "20240928"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (60290-088-03)", "package_ndc": "60290-088-03", "marketing_start_date": "20240928"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-088-04)", "package_ndc": "60290-088-04", "marketing_start_date": "20240928"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (60290-088-05)", "package_ndc": "60290-088-05", "marketing_start_date": "20251030"}], "brand_name": "Diclofenac Potassium", "product_id": "60290-088_4580535c-79b7-68b5-e063-6394a90a38a9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60290-088", "generic_name": "Diclofenac Potassium Tablets", "labeler_name": "Umedica Laboratories USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Potassium", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "25 mg/1"}], "application_number": "ANDA215750", "marketing_category": "ANDA", "marketing_start_date": "20220512", "listing_expiration_date": "20261231"}