FDA.reportPublic FDA data

Guanfacine Hydrochloride

Product NDC
65162-713
11-digit product format
651620713
Labeler code
65162
Product ID
65162-713_2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA075109
Marketing category
ANDA
Marketing start
1998-11-25
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
Guanfacine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui197745, 197746

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
65162-713-03Guanfacine Hydrochloride30 in 1 BOTTLETABLET3013
65162-713-10Guanfacine Hydrochloride100 in 1 BOTTLETABLET10013
65162-713-50Guanfacine Hydrochloride500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-713-10EA - Each65162-7134a48ed1a-7349-4af4-ad3a-88596f84c6f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-713GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 3 package rows20241027_d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e13
197746guanFACINE HCl 2 MG Oral TabletPSNd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e13
197745guanfacine 1 MG Oral TabletSCDd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e13
197746guanfacine 2 MG Oral TabletSCDd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e13
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e13
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSYd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-713-036516207130330 TABLET in 1 BOTTLE (65162-713-03) 30 tablet1998-11-250000-00-00NoNoCurrent
65162-713-1065162071310100 TABLET in 1 BOTTLE (65162-713-10) 100 tablet1998-11-250000-00-00NoNoCurrent
65162-713-5065162071350500 TABLET in 1 BOTTLE (65162-713-50) 500 tablet1998-11-250000-00-00NoNoCurrent