Guanfacine Hydrochloride

Product NDC
42291-310
11-digit product format
422910310
Labeler code
42291
Product ID
42291-310_d57aa7ec-71d1-5d86-e053-2995a90ad25d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA075109
Marketing category
ANDA
Marketing start
2021-07-02
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
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-310-01Guanfacine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-310-01EA - Each42291-31063e2d1c0-f92a-49e7-845e-967e3133c31412021-08-05
42291-310-90EA - Each42291-3101aaba89a-fc4a-4580-b536-63c7ec494e2512013-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-310GUANFACINE HYDROCHLORIDE TABLET [AVKARE]2Legacy NDC, 1 package rows20220114_c624aaeb-890b-78ec-e053-2a95a90aafef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNc624aaeb-890b-78ec-e053-2a95a90aafef2
197745guanfacine 1 MG Oral TabletSCDc624aaeb-890b-78ec-e053-2a95a90aafef2
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYc624aaeb-890b-78ec-e053-2a95a90aafef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-310-0142291031001100 TABLET in 1 BOTTLE (42291-310-01) 100 tablet2021-07-020000-00-00NoNoCurrent
42291-310-904229103109090 TABLET in 1 BOTTLE (42291-310-90) 90 tablet2011-03-030000-00-00NoNoCurrent