Guanfacine

Product NDC
63187-302
11-digit product format
631870302
Labeler code
63187
Product ID
63187-302_daf5900d-9fea-4afd-9cbb-88e9702a7fa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074673
Marketing category
ANDA
Marketing start
2013-12-02
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-302-30Guanfacine30 in 1 BOTTLETABLET303
63187-302-60Guanfacine60 in 1 BOTTLETABLET603
63187-302-90Guanfacine90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-302GUANFACINE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20200818_09442806-db7b-49de-8ffc-e4cb83138349.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN09442806-db7b-49de-8ffc-e4cb831383493
197745guanfacine 1 MG Oral TabletSCD09442806-db7b-49de-8ffc-e4cb831383493
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY09442806-db7b-49de-8ffc-e4cb831383493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-302-306318703023030 TABLET in 1 BOTTLE (63187-302-30) 30 tablet2016-05-020000-00-00NoNoCurrent
63187-302-606318703026060 TABLET in 1 BOTTLE (63187-302-60) 60 tablet2016-05-020000-00-00NoNoCurrent
63187-302-906318703029090 TABLET in 1 BOTTLE (63187-302-90) 90 tablet2016-05-020000-00-00NoNoCurrent