FDA.reportPublic FDA data

Guanfacine

Product NDC
50090-5991
11-digit product format
500905991
Labeler code
50090
Product ID
50090-5991_47be8a5c-02fd-4066-aa4d-28696b35bf8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201408
Marketing category
ANDA
Marketing start
2017-07-07
Marketing end
0000-00-00
Substance
GUANFACINE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5991-02024-01-30C16284748780-11030e364-fec7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5991-0Guanfacine Extended-Release90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5991-0EA - Each50090-599192e79ed1-1a1c-4f4e-8115-286ba3be06dc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5991GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20220617_6b8b3273-aa80-4481-aecc-4e3fc1ba04dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN6b8b3273-aa80-4481-aecc-4e3fc1ba04dd1
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD6b8b3273-aa80-4481-aecc-4e3fc1ba04dd1
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY6b8b3273-aa80-4481-aecc-4e3fc1ba04dd1
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY6b8b3273-aa80-4481-aecc-4e3fc1ba04dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5991-05009059910090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5991-0) 2022-06-090000-00-00NoNoCurrent