FDA.reportPublic FDA data

Guanfacine

Product NDC
63629-8161
11-digit product format
636298161
Labeler code
63629
Product ID
63629-8161_846438f0-3355-4455-a7e8-f0db48bc6162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205689
Marketing category
ANDA
Marketing start
2018-08-17
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
Rxcui862006

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
63629-8161-12024-05-13C16284748780-11030e365-44c0-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION These 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
63629-8161-12024-01-30C16284748780-11030e365-44c0-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION These 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
63629-8161-1Guanfacine30 in 1 BOTTLETABLET, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8161GUANFACINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 1 package rows20250221_f070a54a-2738-4ef2-a98a-f9e7a7a56f55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSNf070a54a-2738-4ef2-a98a-f9e7a7a56f555
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCDf070a54a-2738-4ef2-a98a-f9e7a7a56f555
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSYf070a54a-2738-4ef2-a98a-f9e7a7a56f555
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSYf070a54a-2738-4ef2-a98a-f9e7a7a56f555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8161-16362981610130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8161-1) 2019-07-020000-00-00NoNoCurrent