FDA.reportPublic FDA data

Guanfacine

Product NDC
50090-7129
11-digit product format
500907129
Labeler code
50090
Product ID
50090-7129_c8bbffbf-2bd0-458a-b874-6e9b8327f402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213428
Marketing category
ANDA
Marketing start
2022-08-01
Substance
GUANFACINE HYDROCHLORIDE
Active strength
3 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 HYDROCHLORIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862019

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
50090-7129-0Guanfacine90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7129-0EA - Each50090-7129bb024923-efc9-4f9e-ae6d-bc2b31f42c2c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7129GUANFACINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240417_57b8ad03-a5d1-4218-8d3a-40b211da84e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN57b8ad03-a5d1-4218-8d3a-40b211da84e61
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD57b8ad03-a5d1-4218-8d3a-40b211da84e61
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY57b8ad03-a5d1-4218-8d3a-40b211da84e61
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY57b8ad03-a5d1-4218-8d3a-40b211da84e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7129-05009071290090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7129-0) 2024-04-11NoNoCurrent