nabumetone

Generic: nabumetone

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

Drug Facts

Product Profile

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

nabumetone 500 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-965
Product ID 69097-965_46daea72-1c6d-41ce-b8d0-c412ca0d908e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078671
Listing Expiration 2026-12-31
Marketing Start 2019-03-06

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 69097965
Hyphenated Format 69097-965

Supplemental Identifiers

RxCUI
311892 311893
UPC
0369097966072 0369097965075
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 ANDA078671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69097-965-07)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69097-965-12)
source: ndc

Packages (2)

69097-965-07 100 TABLET, FILM COATED in 1 BOTTLE (69097-965-07) 69097-965-12 500 TABLET, FILM COATED in 1 BOTTLE (69097-965-12)

Ingredients (1)

nabumetone (500 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": "46daea72-1c6d-41ce-b8d0-c412ca0d908e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369097966072", "0369097965075"], "unii": ["LW0TIW155Z"], "rxcui": ["311892", "311893"], "spl_set_id": ["85954380-a520-46d7-89ac-e4b19d6e00a1"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69097-965-07)", "package_ndc": "69097-965-07", "marketing_start_date": "20190306"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69097-965-12)", "package_ndc": "69097-965-12", "marketing_start_date": "20190306"}], "brand_name": "Nabumetone", "product_id": "69097-965_46daea72-1c6d-41ce-b8d0-c412ca0d908e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69097-965", "generic_name": "Nabumetone", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nabumetone", "active_ingredients": [{"name": "NABUMETONE", "strength": "500 mg/1"}], "application_number": "ANDA078671", "marketing_category": "ANDA", "marketing_start_date": "20190306", "listing_expiration_date": "20261231"}