FDA.reportPublic FDA data

Guanfacine Hydrochloride

Product NDC
68094-065
11-digit product format
680940065
Labeler code
68094
Product ID
68094-065_370c543f-fc34-4fff-804c-3b990de04588
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA075109
Marketing category
ANDA
Marketing start
2023-01-31
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 Hydrochloride
Listing expiration
2026-12-31

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
68094-065-59Guanfacine Hydrochloride10 in 1 BLISTER PACKTABLET102
68094-065-62Guanfacine Hydrochloride3 in 1 CARTONTABLET32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-065-59EA - Each68094-0655f870357-588e-46b1-9548-718e84b3860b12023-04-07
68094-065-62EA - Each68094-065c9cf849f-adca-4a55-9ee4-7caff5fb626312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-065GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [PRECISION DOSE, INC.]1Current NDC, 2 package rows20230131_a80dfdc4-b9a7-4f8e-af67-dea30bc063ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNa80dfdc4-b9a7-4f8e-af67-dea30bc063ac2
197745guanfacine 1 MG Oral TabletSCDa80dfdc4-b9a7-4f8e-af67-dea30bc063ac2
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYa80dfdc4-b9a7-4f8e-af67-dea30bc063ac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-065-596809400655910 in 1 BLISTER PACKHistorical
68094-065-62680940065623 BLISTER PACK in 1 CARTON (68094-065-62) / 10 TABLET in 1 BLISTER PACK (68094-065-59) 3 blister pack2023-01-31NoNoHistorical