FDA.reportPublic FDA data

Naltrexone Hydrochloride

Product NDC
72162-1566
11-digit product format
721621566
Labeler code
72162
Product ID
72162-1566_a3b74230-f1bf-4ab3-934d-fb9f43cfae3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075274
Marketing category
ANDA
Marketing start
2013-09-23
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
72162-1566-1Naltrexone Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100101
72162-1566-3Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1566-1EA - Each72162-1566bfe1c44e-2040-45eb-9f1c-577a01cdd91712024-03-12
72162-1566-3EA - Each72162-156667424c5e-98fe-4c9e-ad53-772ee960167512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1566NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20231206_49b7b694-6fec-479b-be35-d03d816e13dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSN49b7b694-6fec-479b-be35-d03d816e13dd101
1483744naltrexone hydrochloride 50 MG Oral TabletSCD49b7b694-6fec-479b-be35-d03d816e13dd101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1566-172162156601100 TABLET, FILM COATED in 1 BOTTLE (72162-1566-1) 2023-09-12NoNoHistorical
72162-1566-37216215660330 TABLET, FILM COATED in 1 BOTTLE (72162-1566-3) 2023-09-12NoNoHistorical