Naltrexone Hydrochloride

Product NDC
50090-2866
11-digit product format
500902866
Labeler code
50090
Product ID
50090-2866_03019873-ea2b-4b8b-8b9d-47777f800322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075274
Marketing category
ANDA
Marketing start
2013-09-23
Marketing end
0000-00-00
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31849934-38d8-47fe-b84a-4d392838c14bProduct name120170823
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2866-02023-01-30C16284748780-1f386c649-f736-0266-e053-dadaa90a7c1aNaltrexone Hydrochloride Tablets, USP 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2866-0Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2866-0EA - Each50090-286671485bb1-d54f-491a-a065-7ef67e5af9f612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2866NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Legacy NDC, 1 package rows20200121_13359275-0a7f-48c8-b14a-588d7c0b5f84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSN13359275-0a7f-48c8-b14a-588d7c0b5f8412
1483744naltrexone hydrochloride 50 MG Oral TabletSCD13359275-0a7f-48c8-b14a-588d7c0b5f8412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2866-05009028660030 TABLET, FILM COATED in 1 BOTTLE (50090-2866-0) 2017-02-140000-00-00NoNoCurrent