FDA.reportPublic FDA data

Guanfacine

Product NDC
63304-927
11-digit product format
633040927
Labeler code
63304
Product ID
63304-927_2a401634-d240-7d00-e063-6394a90abb3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc
Application
ANDA205689
Marketing category
ANDA
Marketing start
2018-08-17
Substance
GUANFACINE HYDROCHLORIDE
Active strength
4 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE4 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
63304-927-01Guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE10014
63304-927-05Guanfacine500 in 1 BOTTLETABLET, EXTENDED RELEASE50014
63304-927-30Guanfacine30 in 1 BOTTLETABLET, EXTENDED RELEASE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-927-01EA - Each63304-9277f4d418e-43e0-4afe-8be6-02a6ef7f809012018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-927GUANFACINE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC]14Current NDC, Legacy NDC, 3 package rows20250101_2d0a0f8e-5098-4ee2-a4ee-d026789923e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSNc20cc7eb-9de5-407a-8943-c4d2e3f78444101
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCDc20cc7eb-9de5-407a-8943-c4d2e3f78444101
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSYc20cc7eb-9de5-407a-8943-c4d2e3f78444101
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSYc20cc7eb-9de5-407a-8943-c4d2e3f78444101
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN2d0a0f8e-5098-4ee2-a4ee-d026789923e214
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD2d0a0f8e-5098-4ee2-a4ee-d026789923e214
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD2d0a0f8e-5098-4ee2-a4ee-d026789923e214
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD2d0a0f8e-5098-4ee2-a4ee-d026789923e214
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY2d0a0f8e-5098-4ee2-a4ee-d026789923e214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-927-0163304092701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-01) 2018-08-170000-00-00NoNoCurrent
63304-927-0563304092705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-05) 2018-08-170000-00-00NoNoCurrent
63304-927-306330409273030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-30) 2018-08-170000-00-00NoNoCurrent