FDA.reportPublic FDA data

Guanfacine

Product NDC
71205-946
11-digit product format
712050946
Labeler code
71205
Product ID
71205-946_6de48883-f40b-4aef-83d4-6acb86c1b11e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201408
Marketing category
ANDA
Marketing start
2017-07-07
Substance
GUANFACINE
Active strength
3 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

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
71205-946-00GuanfacineExtended-Release100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
71205-946-30GuanfacineExtended-Release30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-946-55GuanfacineExtended-Release500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
71205-946-60GuanfacineExtended-Release60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-946-90GuanfacineExtended-Release90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-946-00EA - Each71205-946c0f99b13-e9a6-4b07-b40f-24477d0fa3d412021-06-02
71205-946-30EA - Each71205-94664c1478a-098c-4ce6-a8dd-e26f0ace7d6812021-09-07
71205-946-55EA - Each71205-946bbdddb1f-4e60-4ea6-a863-36cf7451412812021-06-02
71205-946-60EA - Each71205-946b1d6c278-d68f-4185-9490-d7eaf5a7010612021-06-02
71205-946-90EA - Each71205-94669973bd3-6173-4944-aaeb-5378b07cdac912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-946GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20220426_6460ad33-4feb-4a4d-9958-501084046389.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-946-0071205094600100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-00) 2020-11-190000-00-00NoNoCurrent
71205-946-307120509463030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-30) 2020-11-190000-00-00NoNoCurrent
71205-946-5571205094655500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-55) 2020-11-190000-00-00NoNoCurrent
71205-946-607120509466060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-60) 2020-11-190000-00-00NoNoCurrent
71205-946-907120509469090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-946-90) 2020-11-190000-00-00NoNoCurrent