FDA.reportPublic FDA data

Guanfacine

Product NDC
42806-048
11-digit product format
428060048
Labeler code
42806
Product ID
42806-048_d0ca35de-12e8-4154-825a-c82eed36efd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
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, 197746

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
42806-048-01Guanfacine100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-048-01EA - Each42806-048ffd6dc9c-f61e-4723-b113-bac5f3e2dbf812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE TABLET [EPIC PHARMA, LLC]3
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE TABLET [EPIC PHARMA, LLC]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGUANFACINE TABLET [EPIC PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE TABLET [EPIC PHARMA, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGUANFACINE TABLET [EPIC PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GUANFACINE TABLET [EPIC PHARMA, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGUANFACINE TABLET [EPIC PHARMA, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGUANFACINE TABLET [EPIC PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-048GUANFACINE TABLET [EPIC PHARMA, LLC]12Current NDC, Legacy NDC, 1 package rows20231221_fac4a4c2-f5f0-46ef-b76b-315abe9136fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNfac4a4c2-f5f0-46ef-b76b-315abe9136fa12
197746guanFACINE HCl 2 MG Oral TabletPSNfac4a4c2-f5f0-46ef-b76b-315abe9136fa12
197745guanfacine 1 MG Oral TabletSCDfac4a4c2-f5f0-46ef-b76b-315abe9136fa12
197746guanfacine 2 MG Oral TabletSCDfac4a4c2-f5f0-46ef-b76b-315abe9136fa12
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYfac4a4c2-f5f0-46ef-b76b-315abe9136fa12
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSYfac4a4c2-f5f0-46ef-b76b-315abe9136fa12
197745guanFACINE HCl 1 MG Oral TabletPSN400be431-ad6c-4783-a513-ca8b47bf43ee5
197745guanfacine 1 MG Oral TabletSCD400be431-ad6c-4783-a513-ca8b47bf43ee5
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY400be431-ad6c-4783-a513-ca8b47bf43ee5
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
42806-048-0142806004801100 TABLET in 1 BOTTLE (42806-048-01) 100 tablet2013-12-020000-00-00NoNoCurrent