Guanfacine extended-release

Product NDC
71335-2852
11-digit product format
713352852
Labeler code
71335
Product ID
71335-2852_d2293e0c-0dd5-4024-89b1-826f81fe532c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205430
Marketing category
ANDA
Marketing start
2018-10-03
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
PML56A160OGUANFACINE HYDROCHLORIDE29110-48-3GUANFACINE HYDROCHLORIDE
30OMY4G3MKGUANFACINE29110-47-2guanfacine

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2852-171335285201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2852-1) 2025-10-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Guanfacine extended-releaseBryant Ranch Prepack2025-10-30HUMAN PRESCRIPTION DRUG LABEL100