FDA.reportPublic FDA data

Guanfacine Hydrochloride

Product NDC
60687-710
11-digit product format
606870710
Labeler code
60687
Product ID
60687-710_20d4dc32-fa9a-d4dd-e063-6394a90a3861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA214689
Marketing category
ANDA
Marketing start
2023-11-09
Substance
GUANFACINE
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
GUANFACINE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30OMY4G3MK
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
60687-710-11Guanfacine Hydrochloride1 in 1 BLISTER PACKTABLET13
60687-710-21Guanfacine Hydrochloride30 in 1 CARTONTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-710-11EA - Each60687-7106cdffb2a-ee36-4a9b-8094-7abb8e8d75b012023-02-06
60687-710-21EA - Each60687-710b942c4e3-f16a-4e95-9f44-cb974717decf12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-710GUANFACINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20240830_c38bf26f-8a98-4baa-9abb-c83f812900a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNc38bf26f-8a98-4baa-9abb-c83f812900a13
197745guanfacine 1 MG Oral TabletSCDc38bf26f-8a98-4baa-9abb-c83f812900a13
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYc38bf26f-8a98-4baa-9abb-c83f812900a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-710-11606870710111 in 1 BLISTER PACKHistorical
60687-710-216068707102130 BLISTER PACK in 1 CARTON (60687-710-21) / 1 TABLET in 1 BLISTER PACK (60687-710-11) 30 blister pack2023-11-090000-00-00NoNoCurrent