FDA.reportPublic FDA data

Naltrexone Hydrochloride

Product NDC
72162-2311
11-digit product format
721622311
Labeler code
72162
Product ID
72162-2311_6623ade9-5a3d-48fe-8b29-e9e471ef0061
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
Marketing end
2028-06-30
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naltrexone Hydrochloride

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
72162-2311-1Naltrexone Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100105
72162-2311-3Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2311-1EA - Each72162-2311be033ba4-491b-4fb2-816f-0ea656a7b21b12024-06-10
72162-2311-3EA - Each72162-231181b8718b-d5ea-42f4-9c41-434d0c50ec7f12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2311NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 2 package rows20240809_d8433c5e-deb3-4f20-aaf6-9fed6bc44974.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNd8433c5e-deb3-4f20-aaf6-9fed6bc44974105
1483744naltrexone hydrochloride 50 MG Oral TabletSCDd8433c5e-deb3-4f20-aaf6-9fed6bc44974105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72162-2311-172162231101100 TABLET, FILM COATED in 1 BOTTLE (72162-2311-1) 2024-02-152028-06-30NoNoHistorical
72162-2311-37216223110330 TABLET, FILM COATED in 1 BOTTLE (72162-2311-3) 2024-02-152028-06-30NoNoHistorical