NALTREXONE HYDROCHLORIDE

Product NDC
51407-959
11-digit product format
514070959
Labeler code
51407
Product ID
51407-959_3cbd097c-11db-6e77-e063-6294a90a3c7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
51407-959-01NALTREXONE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1001
51407-959-30NALTREXONE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-959-01EA - Each51407-9595ef3f995-5d85-4f97-b102-dec7fdb02b5b12025-09-12
51407-959-30EA - Each51407-95912448b7c-23e7-4536-835e-e085861151e212025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSN3cbd0cad-7c56-ac0a-e063-6294a90a80e41
1483744naltrexone HCl 50 MG Oral TabletPSN43cd6961-4793-85ee-e063-6294a90ad7721
1483744naltrexone hydrochloride 50 MG Oral TabletSCD3cbd0cad-7c56-ac0a-e063-6294a90a80e41
1483744naltrexone hydrochloride 50 MG Oral TabletSCD43cd6961-4793-85ee-e063-6294a90ad7721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-959-0151407095901100 TABLET, FILM COATED in 1 BOTTLE (51407-959-01) 2025-06-11NoNoCurrent
51407-959-305140709593030 TABLET, FILM COATED in 1 BOTTLE (51407-959-30) 2025-06-11NoNoCurrent