Guanfacine

Product NDC
72162-1801
11-digit product format
721621801
Labeler code
72162
Product ID
72162-1801_50c35259-c035-46e9-bfb1-ff5121e6aec4
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
Substance
GUANFACINE HYDROCHLORIDE
Active strength
4 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

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862025

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
72162-1801-1Guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1801GUANFACINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250308_c20cc7eb-9de5-407a-8943-c4d2e3f78444.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSNc20cc7eb-9de5-407a-8943-c4d2e3f78444101
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCDc20cc7eb-9de5-407a-8943-c4d2e3f78444101
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSYc20cc7eb-9de5-407a-8943-c4d2e3f78444101
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSYc20cc7eb-9de5-407a-8943-c4d2e3f78444101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1801-172162180101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1801-1) 2018-08-17NoNoHistorical