FDA.reportPublic FDA data

Guanfacine extended-release

Product NDC
71335-9750
11-digit product format
713359750
Labeler code
71335
Product ID
71335-9750_9de936f2-fd38-401b-a195-960f037b5e8c
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862013

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
71335-9750-1Guanfacine extended-release30 in 1 BOTTLETABLET, EXTENDED RELEASE30103
71335-9750-2Guanfacine extended-release90 in 1 BOTTLETABLET, EXTENDED RELEASE90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9750GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20241018_07cda4a1-0eb5-491e-8d16-4e6a6feb93ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN07cda4a1-0eb5-491e-8d16-4e6a6feb93ac103
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD07cda4a1-0eb5-491e-8d16-4e6a6feb93ac103
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY07cda4a1-0eb5-491e-8d16-4e6a6feb93ac103
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY07cda4a1-0eb5-491e-8d16-4e6a6feb93ac103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9750-17133597500130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-1) 2023-07-10NoNoHistorical
71335-9750-27133597500290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-2) 2024-10-04NoNoHistorical