FDA.reportPublic FDA data

Guanfacine

Product NDC
24979-533
11-digit product format
249790533
Labeler code
24979
Product ID
24979-533_6634768f-1e5a-4604-9587-fe5ffbd7e331
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA201408
Marketing category
ANDA
Marketing start
2017-07-07
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
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30OMY4G3MK
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
24979-533-00Guanfacine Extended-Release100000 in 1 DRUMTABLET, EXTENDED RELEASE10000015
24979-533-01Guanfacine Extended-Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10015
24979-533-10Guanfacine Extended-Release1000 in 1 BOTTLETABLET, EXTENDED RELEASE100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-533-01EA - Each24979-533af3aed04-8f1e-48bb-8b9a-bc7e6c87a27d12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-533GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]15Current NDC, Legacy NDC, 3 package rows20250430_07a701e2-39b7-4bb1-a7c7-d9baed4ab18a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY07a701e2-39b7-4bb1-a7c7-d9baed4ab18a15
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN6006df06-0448-462d-b81e-7add50a6d71b12
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN6006df06-0448-462d-b81e-7add50a6d71b12
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN6006df06-0448-462d-b81e-7add50a6d71b12
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN6006df06-0448-462d-b81e-7add50a6d71b12
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD6006df06-0448-462d-b81e-7add50a6d71b12
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD6006df06-0448-462d-b81e-7add50a6d71b12
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD6006df06-0448-462d-b81e-7add50a6d71b12
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD6006df06-0448-462d-b81e-7add50a6d71b12
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY6006df06-0448-462d-b81e-7add50a6d71b12
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN6460ad33-4feb-4a4d-9958-5010840463892
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN6460ad33-4feb-4a4d-9958-5010840463892
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN6460ad33-4feb-4a4d-9958-5010840463892
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN6460ad33-4feb-4a4d-9958-5010840463892
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD6460ad33-4feb-4a4d-9958-5010840463892
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD6460ad33-4feb-4a4d-9958-5010840463892
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD6460ad33-4feb-4a4d-9958-5010840463892
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD6460ad33-4feb-4a4d-9958-5010840463892
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY6460ad33-4feb-4a4d-9958-5010840463892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-533-0024979053300100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-533-00) 2024-07-01NoNoHistorical
24979-533-0124979053301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-533-01) 2017-07-070000-00-00NoNoCurrent
24979-533-10249790533101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-533-10) 2017-07-070000-00-00NoNoCurrent