FDA.reportPublic FDA data

Intuniv

Product NDC
54092-515
11-digit product format
540920515
Labeler code
54092
Product ID
54092-515_448b4d80-7441-4a2f-839f-c61052d6e83a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA022037
Marketing category
NDA
Marketing start
2009-09-02
Substance
GUANFACINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Intuniv
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862006, 862010, 862013, 862015, 862019, 862021, 862025, 862027, 1092566, 1092567

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-515-02Intuniv100 in 1 BOTTLETABLET, EXTENDED RELEASE10044
54092-515-03Intuniv7 in 1 BOTTLETABLET, EXTENDED RELEASE744

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-515-02EA - Each54092-5158e6ef50d-4d2f-480b-bc54-4921bcca6b4412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
GUANFACINEACTIVE MOIETY30OMY4G3MKINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
CROSPOVIDONEINACTIVE INGREDIENT68401960MKINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
POVIDONESINACTIVE INGREDIENTFZ989GH94EINTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]27
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
54092-515INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]42Current NDC, Legacy NDC, 2 package rows20250511_b972af81-3a37-40be-9fe1-3ddf59852528.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092567{7 (24 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]) } Pack [Intuniv Kit 7/7]BPCKb972af81-3a37-40be-9fe1-3ddf5985252844
1092566{7 (24 HR guanfacine 1 MG Extended Release Oral Tablet) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet) } PackGPCKb972af81-3a37-40be-9fe1-3ddf5985252844
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
1092566guanFACINE 1 MG 24HR Extended Release Oral Tablet (7) / guanFACINE 2 MG 24HR Extended Release Oral Tablet (7) PackPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862010intuniv 1 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862015intuniv 2 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862021intuniv 3 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
862027intuniv 4 MG 24HR Extended Release Oral TabletPSNb972af81-3a37-40be-9fe1-3ddf5985252844
1092567Intuniv Kit 7/7PSNb972af81-3a37-40be-9fe1-3ddf5985252844
86201024 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]SBDb972af81-3a37-40be-9fe1-3ddf5985252844
86201524 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]SBDb972af81-3a37-40be-9fe1-3ddf5985252844
86202124 HR guanfacine 3 MG Extended Release Oral Tablet [Intuniv]SBDb972af81-3a37-40be-9fe1-3ddf5985252844
86202724 HR guanfacine 4 MG Extended Release Oral Tablet [Intuniv]SBDb972af81-3a37-40be-9fe1-3ddf5985252844
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCDb972af81-3a37-40be-9fe1-3ddf5985252844
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCDb972af81-3a37-40be-9fe1-3ddf5985252844
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCDb972af81-3a37-40be-9fe1-3ddf5985252844
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCDb972af81-3a37-40be-9fe1-3ddf5985252844
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862010Intuniv 1 MG (guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862010Intuniv 1 MG 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862015Intuniv 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862015Intuniv 2 MG 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862021Intuniv 3 MG (guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862021Intuniv 3 MG 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862027Intuniv 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
862027Intuniv 4 MG 24 HR Extended Release Oral TabletSYb972af81-3a37-40be-9fe1-3ddf5985252844
1092567Intuniv Kit 7/7SYb972af81-3a37-40be-9fe1-3ddf5985252844
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54092-515-0254092051502100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-02) 2009-09-020000-00-00NoNoCurrent
54092-515-03540920515037 in 1 BOTTLEHistorical