Guanfacine

Product NDC
24658-730
11-digit product format
246580730
Labeler code
24658
Product ID
24658-730_51536f5a-dca8-49b1-97f4-cb6f696c4154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application
ANDA074673
Marketing category
ANDA
Marketing start
2016-11-14
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
24658-730-01Guanfacine100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-730-01EA - Each24658-7305ab904fc-9ca3-43a8-8c60-2e3aa9377bbe12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-730GUANFACINE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]4Current NDC, Legacy NDC, 1 package rows20190105_ba089e4c-8623-4159-8230-5c7fd02cdb12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNba089e4c-8623-4159-8230-5c7fd02cdb126
197746guanFACINE HCl 2 MG Oral TabletPSNba089e4c-8623-4159-8230-5c7fd02cdb126
197745guanfacine 1 MG Oral TabletSCDba089e4c-8623-4159-8230-5c7fd02cdb126
197746guanfacine 2 MG Oral TabletSCDba089e4c-8623-4159-8230-5c7fd02cdb126
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYba089e4c-8623-4159-8230-5c7fd02cdb126
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSYba089e4c-8623-4159-8230-5c7fd02cdb126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24658-730-0124658073001100 TABLET in 1 BOTTLE (24658-730-01) 100 tablet2016-11-140000-00-00NoNoCurrent