Guanfacine

Product NDC
63629-1103
11-digit product format
636291103
Labeler code
63629
Product ID
63629-1103_7cd9c4eb-c6e9-488d-a0f4-5eca80b5284f
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
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1103-1EA - Each63629-11032cb04910-33dd-43ae-84db-3230e9c05d4612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1103GUANFACINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Legacy NDC20250209_f2131264-a8c6-4028-88e5-e4127dcefe4e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1103-163629110301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1103-1) 2022-11-090000-00-00NoNoCurrent