NALTREXONE HYDROCHLORIDE

Product NDC
72162-2154
11-digit product format
721622154
Labeler code
72162
Product ID
72162-2154_ba53c1a1-0bc1-444f-9dc8-fbd07df724d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076264
Marketing category
ANDA
Marketing start
2002-03-22
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NALTREXONE HYDROCHLORIDE
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2154-3NALTREXONE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2154-3EA - Each72162-2154a8ed2e72-48f0-4e17-9b34-323422fb91d712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2154NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231209_10261f2f-e4c1-415c-b722-edeaab97a112.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSN10261f2f-e4c1-415c-b722-edeaab97a112100
1483744naltrexone hydrochloride 50 MG Oral TabletSCD10261f2f-e4c1-415c-b722-edeaab97a112100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2154-37216221540330 TABLET, FILM COATED in 1 BOTTLE (72162-2154-3) 2023-12-07NoNoCurrent