Naltrexone Hydrochloride

Product NDC
68071-2721
11-digit product format
680712721
Labeler code
68071
Product ID
68071-2721_df73db00-ef4d-4e7c-e053-2a95a90a62fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmceuticals,Inc.
Application
ANDA091205
Marketing category
ANDA
Marketing start
2012-01-18
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
2023-12-31
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
68071-2721-32025-01-30C16284748780-12cef2736-8596-d83d-e063-dadaa90ab31fNaltrexone Hydrochloride Tablets USP 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2721-3Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2721NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMCEUTICALS,INC.]1Legacy NDC, 1 package rows20220521_df73d163-8fd0-3c8f-e053-2a95a90a832e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNdf73d163-8fd0-3c8f-e053-2a95a90a832e1
1483744naltrexone hydrochloride 50 MG Oral TabletSCDdf73d163-8fd0-3c8f-e053-2a95a90a832e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2721-36807127210330 TABLET, FILM COATED in 1 BOTTLE (68071-2721-3) 2022-05-200000-00-00NoNoCurrent