FDA.reportPublic FDA data

guanfacine

Product NDC
42291-324
11-digit product format
422910324
Labeler code
42291
Product ID
42291-324_435760cc-e7f3-28b9-e063-6294a90a7004
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA200881
Marketing category
ANDA
Marketing start
2015-07-09
Substance
GUANFACINE HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 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
42291-324-01guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-324-01EA - Each42291-3249ea0aa0b-bb72-4e0c-806d-39807fa53f5812015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
42291-324GUANFACINE TABLET, EXTENDED RELEASE [AVKARE]8Current NDC, Legacy NDC, 1 package rows20240110_301f01a7-2b0a-cfba-9c3d-a1dd831785a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
42291-324-0142291032401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-324-01) 2015-07-090000-00-00NoNoCurrent