Naltrexone Hydrochloride

Product NDC
50090-3076
11-digit product format
500903076
Labeler code
50090
Product ID
50090-3076_9d09ae34-8011-4c2e-9a7f-f039f0e58768
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
2022-12-31
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
50090-3076-02023-01-30C16284748780-1f386c649-d229-0266-e053-dadaa90a7c1aNaltrexone Hydrochloride Tablets, USP 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3076-0Naltrexone Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED103
50090-3076-0Naltrexone Hydrochloride3 in 1 CARTONTABLET, FILM COATED33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3076-0EA - Each50090-3076a7ad5e39-b234-4177-b337-384a75dfabbf12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3076NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210902_48f0b37b-b1cb-4cc9-ae58-4695e9a501e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSN48f0b37b-b1cb-4cc9-ae58-4695e9a501e13
1483744naltrexone hydrochloride 50 MG Oral TabletSCD48f0b37b-b1cb-4cc9-ae58-4695e9a501e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3076-0500903076003 BLISTER PACK in 1 CARTON (50090-3076-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2017-06-270000-00-00NoNoCurrent