FDA.reportPublic FDA data

Intuniv

Product NDC
64725-0513
11-digit product format
647250513
Labeler code
64725
Product ID
64725-0513_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
NDA022037
Marketing category
NDA
Marketing start
2009-09-02
Marketing end
0000-00-00
Substance
GUANFACINE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0513-12020-01-31C16284748780-19d75b9d0-bd13-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use INTUNIV safely and effectively. See full prescribing information for INTUNIV . INTUNIV (guanfacine) extended-release tablets, for oral use Initial U.S. Approval: 1986 ® ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0513-1Intuniv100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
GUANFACINEACTIVE MOIETY30OMY4G3MKINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0513INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]4Legacy NDC, 1 package rows20141019_1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862010intuniv 1 MG 24HR Extended Release Oral TabletPSN1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862015intuniv 2 MG 24HR Extended Release Oral TabletPSN1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
86201024 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]SBD1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
86201524 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]SBD1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862010Intuniv 1 MG (guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862010Intuniv 1 MG 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862015Intuniv 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474
862015Intuniv 2 MG 24 HR Extended Release Oral TabletSY1bb3fac5-11e8-4d1c-a5e4-2520abcdeb474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0513-164725051301100 in 1 BOTTLEHistorical