FDA.reportPublic FDA data

Guanfacine

Product NDC
0591-0444
11-digit product format
005910444
Labeler code
0591
Product ID
0591-0444_3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074145
Marketing category
ANDA
Marketing start
1995-10-17
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
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
0591-0444-01Guanfacine100 in 1 BOTTLE, PLASTICTABLET10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0444-01EA - Each0591-04449b8ded0e-9856-44be-8cf7-193516b2f3c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933GUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUANFACINE TABLET [ACTAVIS PHARMA, INC.]12
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUANFACINE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0444GUANFACINE TABLET [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20250130_a81b956b-f004-4426-ba20-375ccf21eb71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNa81b956b-f004-4426-ba20-375ccf21eb7119
197746guanFACINE HCl 2 MG Oral TabletPSNa81b956b-f004-4426-ba20-375ccf21eb7119
197745guanfacine 1 MG Oral TabletSCDa81b956b-f004-4426-ba20-375ccf21eb7119
197746guanfacine 2 MG Oral TabletSCDa81b956b-f004-4426-ba20-375ccf21eb7119
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYa81b956b-f004-4426-ba20-375ccf21eb7119
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSYa81b956b-f004-4426-ba20-375ccf21eb7119
197745guanFACINE HCl 1 MG Oral TabletPSNadf51bff-fa50-4c72-b69e-a869a6a825fa4
197745guanfacine 1 MG Oral TabletSCDadf51bff-fa50-4c72-b69e-a869a6a825fa4
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYadf51bff-fa50-4c72-b69e-a869a6a825fa4
197745guanFACINE HCl 1 MG Oral TabletPSNc6e30fc7-5ad3-41c1-a673-b4db53f2b98f3
197745guanfacine 1 MG Oral TabletSCDc6e30fc7-5ad3-41c1-a673-b4db53f2b98f3
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYc6e30fc7-5ad3-41c1-a673-b4db53f2b98f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0444-0100591044401100 TABLET in 1 BOTTLE, PLASTIC (0591-0444-01) 100 tablet1995-10-170000-00-00NoNoCurrent