FDA.reportPublic FDA data

guanfacine

Product NDC
0228-2853
11-digit product format
002282853
Labeler code
0228
Product ID
0228-2853_b9040df2-42e8-404d-9b90-331dd3efc38c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA200881
Marketing category
ANDA
Marketing start
2014-12-01
Substance
GUANFACINE HYDROCHLORIDE
Active strength
3 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
guanfacine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862006, 862013, 862019, 862025

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
0228-2853-11guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2853-11EA - Each0228-2853d8ad9a5c-2b63-4797-b2a8-9ed1838951cb12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131GUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
GLYCERYL BEHENATE/EICOSADIOATEINACTIVE INGREDIENT73CJJ317SRGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
HYDROXYPROPYL CELLULOSE (TYPE G)INACTIVE INGREDIENTVQ8ZWO78F6GUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EGUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
GLYCERYL BEHENATE/EICOSADIOATEINACTIVE INGREDIENT73CJJ317SRGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE G)INACTIVE INGREDIENTVQ8ZWO78F6GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2853GUANFACINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 1 package rows20221130_3a171942-37af-430d-8b9d-bb678ca2be4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN3a171942-37af-430d-8b9d-bb678ca2be4b22
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN3a171942-37af-430d-8b9d-bb678ca2be4b22
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN3a171942-37af-430d-8b9d-bb678ca2be4b22
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN3a171942-37af-430d-8b9d-bb678ca2be4b22
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD3a171942-37af-430d-8b9d-bb678ca2be4b22
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD3a171942-37af-430d-8b9d-bb678ca2be4b22
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD3a171942-37af-430d-8b9d-bb678ca2be4b22
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD3a171942-37af-430d-8b9d-bb678ca2be4b22
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY3a171942-37af-430d-8b9d-bb678ca2be4b22
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-2853-1100228285311100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2853-11) 2014-12-010000-00-00NoNoCurrent