FDA.reportPublic FDA data

Guanfacine

Product NDC
72888-124
11-digit product format
728880124
Labeler code
72888
Product ID
72888-124_473ce2a5-25a3-811b-e063-6294a90a0456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216762
Marketing category
ANDA
Marketing start
2021-10-01
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
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
72888-124-00Guanfacine1000 in 1 BOTTLETABLET10007
72888-124-01Guanfacine100 in 1 BOTTLETABLET1007
72888-124-05Guanfacine500 in 1 BOTTLETABLET5007
72888-124-30Guanfacine30 in 1 BOTTLETABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-124GUANFACINE TABLET [ADVAGEN PHARMA LTD]1Current NDC, 4 package rows20231024_87e1ad56-a7b9-431d-a5d2-d52fb64735c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN87e1ad56-a7b9-431d-a5d2-d52fb64735c77
197746guanFACINE HCl 2 MG Oral TabletPSN87e1ad56-a7b9-431d-a5d2-d52fb64735c77
197745guanfacine 1 MG Oral TabletSCD87e1ad56-a7b9-431d-a5d2-d52fb64735c77
197746guanfacine 2 MG Oral TabletSCD87e1ad56-a7b9-431d-a5d2-d52fb64735c77
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY87e1ad56-a7b9-431d-a5d2-d52fb64735c77
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY87e1ad56-a7b9-431d-a5d2-d52fb64735c77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-124-00728880124001000 TABLET in 1 BOTTLE (72888-124-00) 1000 tablet2021-10-01NoNoCurrent
72888-124-0172888012401100 TABLET in 1 BOTTLE (72888-124-01) 100 tablet2021-10-01NoNoCurrent
72888-124-0572888012405500 TABLET in 1 BOTTLE (72888-124-05) 500 tablet2021-10-01NoNoCurrent
72888-124-307288801243030 TABLET in 1 BOTTLE (72888-124-30) 30 tablet2021-10-01NoNoCurrent