GUANFACINE

Product NDC
71335-2379
11-digit product format
713352379
Labeler code
71335
Product ID
71335-2379_7db29f50-df23-49b1-ad92-05c42fda4ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GUANFACINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217269
Marketing category
ANDA
Marketing start
2023-08-08
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
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
71335-2379-17133523790130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2379-1) 2024-03-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GUANFACINEBryant Ranch Prepack2025-06-27HUMAN PRESCRIPTION DRUG LABEL2