Guanfacine

Product NDC
63629-1102
11-digit product format
636291102
Labeler code
63629
Product ID
63629-1102_dea1454a-d027-4067-9d30-7eb2cbe74ac0
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
1 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
63629-1102-1EA - Each63629-110200c61a21-117e-48a8-980b-9343ff65077712020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1102GUANFACINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]108Legacy NDC20250209_00f244f8-353d-4674-b479-26aad6b1619a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1102-163629110201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1102-1) 2020-06-170000-00-00NoNoCurrent