Guanfacine Hydrochloride

Product NDC
64725-0711
11-digit product format
647250711
Labeler code
64725
Product ID
64725-0711_f4bba57b-92f5-4850-b329-36ee214dc013
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA075109
Marketing category
ANDA
Marketing start
1998-11-25
Marketing end
0000-00-00
Substance
GUANFACINE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0711-12020-01-31C16284748780-19d75b9d1-14fa-f424-e053-dadaa90a57ceGuanfacine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0711-1Guanfacine Hydrochloride15 in 1 CONTAINERTABLET152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0711GUANFACINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_a2759644-4e9d-4ad3-8dcd-f2a42b036332.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNa2759644-4e9d-4ad3-8dcd-f2a42b0363322
197745guanfacine 1 MG Oral TabletSCDa2759644-4e9d-4ad3-8dcd-f2a42b0363322
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYa2759644-4e9d-4ad3-8dcd-f2a42b0363322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0711-16472507110115 in 1 CONTAINERHistorical