FDA.reportPublic FDA data

Naltrexone Hydrochloride

Product NDC
71335-2419
11-digit product format
713352419
Labeler code
71335
Product ID
71335-2419_e0afc24e-ee9e-4321-bf71-85e84772d1e9
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
2024-02-15
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
71335-2419-1Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30101
71335-2419-2Naltrexone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90101
71335-2419-3Naltrexone Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60101
71335-2419-4Naltrexone Hydrochloride45 in 1 BOTTLETABLET, FILM COATED45101
71335-2419-5Naltrexone Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120101
71335-2419-6Naltrexone Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15101
71335-2419-7Naltrexone Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2419-7EA - Each71335-241934d5b065-2862-46b6-9091-d41249bef43812025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2419NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 7 package rows20241114_d7ba0156-6222-4619-a043-b5a1342d5375.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNd7ba0156-6222-4619-a043-b5a1342d5375101
1483744naltrexone hydrochloride 50 MG Oral TabletSCDd7ba0156-6222-4619-a043-b5a1342d5375101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2419-17133524190130 TABLET, FILM COATED in 1 BOTTLE (71335-2419-1) 2024-11-12NoNoHistorical
71335-2419-27133524190290 TABLET, FILM COATED in 1 BOTTLE (71335-2419-2) 2024-11-12NoNoHistorical
71335-2419-37133524190360 TABLET, FILM COATED in 1 BOTTLE (71335-2419-3) 2024-11-12NoNoHistorical
71335-2419-47133524190445 TABLET, FILM COATED in 1 BOTTLE (71335-2419-4) 2024-11-12NoNoHistorical
71335-2419-571335241905120 TABLET, FILM COATED in 1 BOTTLE (71335-2419-5) 2024-11-12NoNoHistorical
71335-2419-67133524190615 TABLET, FILM COATED in 1 BOTTLE (71335-2419-6) 2024-11-12NoNoHistorical
71335-2419-771335241907100 TABLET, FILM COATED in 1 BOTTLE (71335-2419-7) 2024-11-12NoNoHistorical