Guanfacine Hydrochloride

Product NDC
50268-373
11-digit product format
502680373
Labeler code
50268
Product ID
50268-373_76dd1d5b-cad9-7cb7-e053-2a91aa0a7695
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075109
Marketing category
ANDA
Marketing start
2018-09-27
Marketing end
0000-00-00
Substance
GUANFACINE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-373-11Guanfacine Hydrochloride1 in 1 BLISTER PACKTABLET110
50268-373-15Guanfacine Hydrochloride50 in 1 BOX, UNIT-DOSETABLET5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-373-11EA - Each50268-373ae8147fc-3d02-40a6-ac4e-bc06a55f748112018-11-06
50268-373-15EA - Each50268-373ef64023d-1428-4d20-ad72-a372f2d3de5512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-373GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AVPAK]8Legacy 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 formatDescriptionStatus
50268-373-11502680373111 in 1 BLISTER PACKHistorical
50268-373-155026803731550 in 1 BOX, UNIT-DOSEHistorical