FDA.reportPublic FDA data

Guanfacine extended-release

Product NDC
60505-3927
11-digit product format
605053927
Labeler code
60505
Product ID
60505-3927_be71bf36-161d-d944-6044-1bbe8d133d28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA205430
Marketing category
ANDA
Marketing start
2018-10-03
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 extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862006, 862013, 862019, 862025

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
60505-3927-1Guanfacine extended-release100 in 1 BOTTLETABLET, EXTENDED RELEASE10012
60505-3927-3Guanfacine extended-release30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
60505-3927-8Guanfacine extended-release1000 in 1 BOTTLETABLET, EXTENDED RELEASE100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3927-1EA - Each60505-392791c918cd-d0ba-4a9c-a4c0-271843f3104212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3927GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [APOTEX CORP.]10Current NDC, Legacy NDC, 3 package rows20240927_1c492e87-3406-ddb8-aaf2-e609c2ded503.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN1c492e87-3406-ddb8-aaf2-e609c2ded50312
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN1c492e87-3406-ddb8-aaf2-e609c2ded50312
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN1c492e87-3406-ddb8-aaf2-e609c2ded50312
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN1c492e87-3406-ddb8-aaf2-e609c2ded50312
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD1c492e87-3406-ddb8-aaf2-e609c2ded50312
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD1c492e87-3406-ddb8-aaf2-e609c2ded50312
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD1c492e87-3406-ddb8-aaf2-e609c2ded50312
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD1c492e87-3406-ddb8-aaf2-e609c2ded50312
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY1c492e87-3406-ddb8-aaf2-e609c2ded50312
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSNfae2df3c-2298-a3e1-e053-6294a90aeac42
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCDfae2df3c-2298-a3e1-e053-6294a90aeac42
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSYfae2df3c-2298-a3e1-e053-6294a90aeac42
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSYfae2df3c-2298-a3e1-e053-6294a90aeac42
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN1c5d9514-641a-4c72-a79a-96a0fe5d6fbd1
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD1c5d9514-641a-4c72-a79a-96a0fe5d6fbd1
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY1c5d9514-641a-4c72-a79a-96a0fe5d6fbd1
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY1c5d9514-641a-4c72-a79a-96a0fe5d6fbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3927-160505392701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-1) 2018-10-030000-00-00NoNoCurrent
60505-3927-36050539270330 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-3) 2018-10-030000-00-00NoNoCurrent
60505-3927-8605053927081000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-8) 2018-10-030000-00-00NoNoCurrent