nabumetone

Generic: nabumetone

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nabumetone
Generic Name nabumetone
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nabumetone 750 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-142
Product ID 68180-142_54834b73-96d1-4f73-953d-a3407be454d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090445
Listing Expiration 2026-12-31
Marketing Start 2011-01-12

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180142
Hyphenated Format 68180-142

Supplemental Identifiers

RxCUI
311892 311893
UPC
0368180142010 0368180141013
UNII
LW0TIW155Z
NUI
N0000000160 M0001335 N0000175722

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 nabumetone (source: ndc)
Generic Name nabumetone (source: ndc)
Application Number ANDA090445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Nabumetone Tablets USP, 500 mg are available as white to off white, oval shaped, biconvex, film-coated tablets, debossed with "LU" on one side and "V01" on the other side. They are supplied as follows: NDC 68180-141-01 Bottles of 100's NDC 68180-141-03 Bottles of 1000's Nabumetone Tablets USP, 750 mg are available as white to off white, oval shaped, biconvex, film-coated tablets, debossed with "LU" on one side and "V02" on the other side. They are supplied as follows: NDC 68180-142-01 Bottles of 100's NDC 68180-142-03 Bottles of 1000's Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). _____________________________________________________________________________________________________ 1 Throughout this package insert, the term NSAID refers to a non-aspirin non- steroidal anti-inflammatory drug. 2 Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked. 3 † Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Goa 403722 INDIA August 7, 2015 ID#: 242328
  • PRINCIPAL DISPLAY PANEL NDC 68180-141-01 NABUMETONE TABLETS USP 500 MG Rx only Bottle of 100 Tablets NDC 68180-142-01 NABUMETONE TABLETS USP 750 MG Rx only Bottle of 100 Tablets 500 MG 100 count 750 MG 100s count
source: label

Packages (0)

No package records.

Ingredients (1)

nabumetone (750 mg/1)

Linked Drug Pages (1)

Nabumetone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "54834b73-96d1-4f73-953d-a3407be454d6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368180142010", "0368180141013"], "unii": ["LW0TIW155Z"], "rxcui": ["311892", "311893"], "spl_set_id": ["cf96d189-5417-4181-a5fb-169b269560a2"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Nabumetone", "product_id": "68180-142_54834b73-96d1-4f73-953d-a3407be454d6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68180-142", "generic_name": "nabumetone", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nabumetone", "active_ingredients": [{"name": "NABUMETONE", "strength": "750 mg/1"}], "application_number": "ANDA090445", "marketing_category": "ANDA", "marketing_start_date": "20110112", "listing_expiration_date": "20261231"}