Guanfacine

Product NDC
73141-018
11-digit product format
731410018
Labeler code
73141
Product ID
73141-018_32c1e44a-6ccf-c3c7-e063-6394a90ad7fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gaunfacine
Dosage form
TABLET
Route
ORAL
Labeler
A2A Integrated Pharmaceuticals
Application
ANDA216828
Marketing category
ANDA
Marketing start
2025-04-08
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui197745, 197746

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
73141-018-04Guanfacine100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73141-018GUANFACINE (GAUNFACINE) TABLET [A2A INTEGRATED PHARMACEUTICALS]1Current NDC, 1 package rows20250416_00c3b4d2-fc4d-4e68-9157-eb29d927deaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197746guanFACINE HCl 2 MG Oral TabletPSN00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197745guanfacine 1 MG Oral TabletSCD00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197746guanfacine 2 MG Oral TabletSCD00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY00c3b4d2-fc4d-4e68-9157-eb29d927deaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73141-018-0473141001804100 TABLET in 1 BOTTLE (73141-018-04) 100 tablet2025-04-08NoNoCurrent