FDA.reportPublic FDA data

Guanfacine

Product NDC
63304-925
11-digit product format
633040925
Labeler code
63304
Product ID
63304-925_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
2 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 HYDROCHLORIDE2 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
63304-925-01Guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE10014
63304-925-05Guanfacine500 in 1 BOTTLETABLET, EXTENDED RELEASE50014
63304-925-30Guanfacine30 in 1 BOTTLETABLET, EXTENDED RELEASE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-925-01EA - Each63304-925d1e780e9-5ba8-48a5-9bf0-421bfa1eb0f712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-925GUANFACINE 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
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSNba58a5d0-607b-4dca-a63e-92d8dd81d81b102
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN6e16cf54-c0d7-47ea-b502-c2146fd87f23102
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCDba58a5d0-607b-4dca-a63e-92d8dd81d81b102
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD6e16cf54-c0d7-47ea-b502-c2146fd87f23102
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSYba58a5d0-607b-4dca-a63e-92d8dd81d81b102
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY6e16cf54-c0d7-47ea-b502-c2146fd87f23102
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSYba58a5d0-607b-4dca-a63e-92d8dd81d81b102
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY6e16cf54-c0d7-47ea-b502-c2146fd87f23102
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
63304-925-0163304092501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-925-01) 2018-08-170000-00-00NoNoCurrent
63304-925-0563304092505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-925-05) 2018-08-170000-00-00NoNoCurrent
63304-925-306330409253030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-925-30) 2018-08-170000-00-00NoNoCurrent