FDA.reportPublic FDA data

NALTREXONE HYDROCHLORIDE

Product NDC
70518-2718
11-digit product format
705182718
Labeler code
70518
Product ID
70518-2718_4a7e6def-2379-64a5-e063-6394a90a011d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALTREXONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090356
Marketing category
ANDA
Marketing start
2020-05-01
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NALTREXONE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ6375YW9SF
Rxcui1483744

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
70518-2718-02023-09-05C16284748780-1d6a99b39-4aa2-a426-e053-dadaa90af4c2Naltrexone Hydrochloride Tablets, USP Opioid Antagonist
70518-2718-12023-09-05C16284748780-1d6a99b39-4aa2-a426-e053-dadaa90af4c2Naltrexone Hydrochloride Tablets, USP Opioid Antagonist
70518-2718-02022-01-28C16284748780-1d6a99b39-4aa2-a426-e053-dadaa90af4c2Naltrexone Hydrochloride Tablets, USP Opioid Antagonist
70518-2718-12022-01-28C16284748780-1d6a99b39-4aa2-a426-e053-dadaa90af4c2Naltrexone Hydrochloride Tablets, USP Opioid Antagonist

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2718-0NALTREXONE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-2718-1NALTREXONE HYDROCHLORIDE28 in 1 BLISTER PACKTABLET, FILM COATED288

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2718NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250330_f821dd49-3fa7-4d33-99de-19023ff1ae65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNf821dd49-3fa7-4d33-99de-19023ff1ae658
1483744naltrexone hydrochloride 50 MG Oral TabletSCDf821dd49-3fa7-4d33-99de-19023ff1ae658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2718-07051827180030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2718-0) 2020-05-010000-00-00NoNoCurrent
70518-2718-17051827180128 TABLET, FILM COATED in 1 BLISTER PACK (70518-2718-1) 2020-11-170000-00-00NoNoCurrent