Guanfacine Hydrochloride

Product NDC
50090-6073
11-digit product format
500906073
Labeler code
50090
Product ID
50090-6073_3c848b56-2c4b-488c-a9de-5bce07ed0260
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075109
Marketing category
ANDA
Marketing start
2022-04-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui197745

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
50090-6073-0Guanfacine Hydrochloride30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6073-0EA - Each50090-6073278dece0-83f0-424b-8a20-6018d8f6b98f12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6073GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231118_9f967d68-5aff-4955-8c79-69febf7c38ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN9f967d68-5aff-4955-8c79-69febf7c38ad6
197745guanfacine 1 MG Oral TabletSCD9f967d68-5aff-4955-8c79-69febf7c38ad6
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY9f967d68-5aff-4955-8c79-69febf7c38ad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6073-05009060730030 TABLET in 1 BOTTLE (50090-6073-0) 30 tablet2022-09-140000-00-00NoNoCurrent