FDA.reportPublic FDA data

Naltrexone Hydrochloride

Product NDC
62135-242
11-digit product format
621350242
Labeler code
62135
Product ID
62135-242_1adc57cf-70f9-75b9-e063-6294a90a0de0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA207905
Marketing category
ANDA
Marketing start
2017-07-21
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
62135-242-30Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
62135-242-60Naltrexone Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
62135-242-90Naltrexone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-242-30EA - Each62135-2420627aca8-3bc7-40f9-afd9-1a05c151a46a12022-01-06
62135-242-60EA - Each62135-242e612b220-73d7-44e1-82c3-cb7ccba90c3f12024-07-12
62135-242-90EA - Each62135-2421c33aa40-619e-44ee-af17-772149de83e612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-242NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 3 package rows20240616_adb7c4dc-221a-4d91-9687-0d78913a92ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNadb7c4dc-221a-4d91-9687-0d78913a92ad4
1483744naltrexone hydrochloride 50 MG Oral TabletSCDadb7c4dc-221a-4d91-9687-0d78913a92ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-242-306213502423030 TABLET, FILM COATED in 1 BOTTLE (62135-242-30) 2022-01-050000-00-00NoNoCurrent
62135-242-606213502426060 TABLET, FILM COATED in 1 BOTTLE (62135-242-60) 2024-06-11NoNoHistorical
62135-242-906213502429090 TABLET, FILM COATED in 1 BOTTLE (62135-242-90) 2022-01-050000-00-00NoNoCurrent