FDA.reportPublic FDA data

Guanfacine Hydrochloride

Product NDC
50268-374
11-digit product format
502680374
Labeler code
50268
Product ID
50268-374_4b96421c-395d-065d-e063-6294a90a330b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075109
Marketing category
ANDA
Marketing start
2017-06-07
Substance
GUANFACINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE2 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
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-374-11Guanfacine Hydrochloride1 in 1 BLISTER PACKTABLET110
50268-374-15Guanfacine Hydrochloride50 in 1 BOX, UNIT-DOSETABLET5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-374-11EA - Each50268-37477a46acc-24aa-4ec7-b23a-9c4be19fdf5112017-08-11
50268-374-15EA - Each50268-3745b0c24dc-615e-4d3f-89f0-a049aceac3ce12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-374GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AVPAK]8Current NDC, Legacy NDC, 2 package rows20240110_cc3cc6de-583c-4180-9f4c-9e4c75eb6f38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNcc3cc6de-583c-4180-9f4c-9e4c75eb6f3810
197746guanFACINE HCl 2 MG Oral TabletPSNcc3cc6de-583c-4180-9f4c-9e4c75eb6f3810
197745guanfacine 1 MG Oral TabletSCDcc3cc6de-583c-4180-9f4c-9e4c75eb6f3810
197746guanfacine 2 MG Oral TabletSCDcc3cc6de-583c-4180-9f4c-9e4c75eb6f3810
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYcc3cc6de-583c-4180-9f4c-9e4c75eb6f3810
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSYcc3cc6de-583c-4180-9f4c-9e4c75eb6f3810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-374-11502680374111 in 1 BLISTER PACKHistorical
50268-374-155026803741550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-374-15) / 1 TABLET in 1 BLISTER PACK (50268-374-11) 50 blister pack2017-06-070000-00-00NoNoCurrent