FDA.reportPublic FDA data

Nabumetone

Product NDC
50090-0747
11-digit product format
500900747
Labeler code
50090
Product ID
50090-0747_162a69c0-ff0b-423b-9b11-6977c7852e82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091083
Marketing category
ANDA
Marketing start
2011-06-13
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0747-02023-01-30C16284748780-1f386c64a-312c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0747-22023-01-30C16284748780-1f386c64a-312c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0747-42023-01-30C16284748780-1f386c64a-312c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0747-52023-01-30C16284748780-1f386c64a-312c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0747-72023-01-30C16284748780-1f386c64a-312c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0747-82023-01-30C16284748780-1f386c64a-312c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0747-0Nabumetone60 in 1 BOTTLETABLET, FILM COATED607
50090-0747-2Nabumetone28 in 1 BOTTLETABLET, FILM COATED287
50090-0747-4Nabumetone14 in 1 BOTTLETABLET, FILM COATED147
50090-0747-5Nabumetone20 in 1 BOTTLETABLET, FILM COATED207
50090-0747-7Nabumetone30 in 1 BOTTLETABLET, FILM COATED307
50090-0747-8Nabumetone90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0747-0EA - Each50090-074772b66a8e-967f-40b0-895c-96f1e157689e12021-08-05
50090-0747-4EA - Each50090-07472ea3c6da-0388-4f5f-a58c-442a1af6487512021-08-05
50090-0747-5EA - Each50090-07479a2ec4d3-3ea2-4d63-861d-e8bf6d0d281612021-08-05
50090-0747-7EA - Each50090-074728b842c0-7890-4031-afb9-8040cfdc1c8712021-08-05
50090-0747-8EA - Each50090-0747ad54f7e5-8e40-4bab-8340-3f2e9fecc5f612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0747NABUMETONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 6 package rows20210416_b0982bef-c543-4ace-8d20-b90b2184e5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNb0982bef-c543-4ace-8d20-b90b2184e5fb7
311892nabumetone 500 MG Oral TabletSCDb0982bef-c543-4ace-8d20-b90b2184e5fb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0747-05009007470060 TABLET, FILM COATED in 1 BOTTLE (50090-0747-0) 2014-11-280000-00-00NoNoCurrent
50090-0747-25009007470228 TABLET, FILM COATED in 1 BOTTLE (50090-0747-2) 2014-11-280000-00-00NoNoCurrent
50090-0747-45009007470414 TABLET, FILM COATED in 1 BOTTLE (50090-0747-4) 2014-11-280000-00-00NoNoCurrent
50090-0747-55009007470520 TABLET, FILM COATED in 1 BOTTLE (50090-0747-5) 2014-11-280000-00-00NoNoCurrent
50090-0747-75009007470730 TABLET, FILM COATED in 1 BOTTLE (50090-0747-7) 2014-11-280000-00-00NoNoCurrent
50090-0747-85009007470890 TABLET, FILM COATED in 1 BOTTLE (50090-0747-8) 2019-07-080000-00-00NoNoCurrent