FDA.reportPublic FDA data

NALTREXONE HYDROCHLORIDE

Product NDC
47335-326
11-digit product format
473350326
Labeler code
47335
Product ID
47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALTREXONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090356
Marketing category
ANDA
Marketing start
2012-02-29
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ6375YW9SF

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
47335-326-08NALTREXONE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1007
47335-326-18NALTREXONE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10007
47335-326-83NALTREXONE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
47335-326-88NALTREXONE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-326-83EA - Each47335-3267603c646-e6c1-4137-b42d-2eac9c1b68db12012-07-24
47335-326-88EA - Each47335-32669d3cb95-b00b-4cd7-9483-948069af4c9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NALTREXONE HYDROCHLORIDEACTIVE INGREDIENTZ6375YW9SFNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
NALTREXONEACTIVE MOIETY5S6W795CQMNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-326NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 4 package rows20231026_0f30f885-d0cd-4fa6-a8e0-142f08a56792.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNf9807ec0-3504-4c66-8efe-ea25f84c782b101
1483744naltrexone hydrochloride 50 MG Oral TabletSCDf9807ec0-3504-4c66-8efe-ea25f84c782b101
1483744naltrexone HCl 50 MG Oral TabletPSNf821dd49-3fa7-4d33-99de-19023ff1ae658
1483744naltrexone hydrochloride 50 MG Oral TabletSCDf821dd49-3fa7-4d33-99de-19023ff1ae658
1483744naltrexone HCl 50 MG Oral TabletPSN0f30f885-d0cd-4fa6-a8e0-142f08a567927
1483744naltrexone hydrochloride 50 MG Oral TabletSCD0f30f885-d0cd-4fa6-a8e0-142f08a567927
1483744naltrexone HCl 50 MG Oral TabletPSN69cb8573-08c1-4957-a768-6cd383f6a3f45
1483744naltrexone hydrochloride 50 MG Oral TabletSCD69cb8573-08c1-4957-a768-6cd383f6a3f45
1483744naltrexone HCl 50 MG Oral TabletPSNe71de213-5250-4a63-9ef7-9ef2f9954d8b4
1483744naltrexone hydrochloride 50 MG Oral TabletSCDe71de213-5250-4a63-9ef7-9ef2f9954d8b4
1483744naltrexone HCl 50 MG Oral TabletPSNf3305f0b-fb9e-4009-b28f-47fe9b1b618b1
1483744naltrexone HCl 50 MG Oral TabletPSNfa2f842f-001a-4f1e-8748-c7852579109c1
1483744naltrexone hydrochloride 50 MG Oral TabletSCDf3305f0b-fb9e-4009-b28f-47fe9b1b618b1
1483744naltrexone hydrochloride 50 MG Oral TabletSCDfa2f842f-001a-4f1e-8748-c7852579109c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-326-0847335032608100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08) 2012-02-290000-00-00NoNoCurrent
47335-326-18473350326181000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18) 2012-02-290000-00-00NoNoCurrent
47335-326-834733503268330 TABLET, FILM COATED in 1 BOTTLE (47335-326-83) 2012-02-290000-00-00NoNoCurrent
47335-326-8847335032688100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88) 2012-02-290000-00-00NoNoCurrent