FDA.reportPublic FDA data

GUANFACINE

Product NDC
46708-747
11-digit product format
467080747
Labeler code
46708
Product ID
46708-747_983b3157-cbea-435d-ba32-9ee7ef95226a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GUANFACINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217269
Marketing category
ANDA
Marketing start
2023-08-08
Substance
GUANFACINE HYDROCHLORIDE
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

Additional Listing Data#

Finished product
Yes
Brand name base
GUANFACINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE3 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
46708-747-31GUANFACINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
46708-747-91GUANFACINE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-747GUANFACINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20230812_983b3157-cbea-435d-ba32-9ee7ef95226a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN983b3157-cbea-435d-ba32-9ee7ef95226a1
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN983b3157-cbea-435d-ba32-9ee7ef95226a1
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN983b3157-cbea-435d-ba32-9ee7ef95226a1
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN983b3157-cbea-435d-ba32-9ee7ef95226a1
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD983b3157-cbea-435d-ba32-9ee7ef95226a1
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD983b3157-cbea-435d-ba32-9ee7ef95226a1
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD983b3157-cbea-435d-ba32-9ee7ef95226a1
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD983b3157-cbea-435d-ba32-9ee7ef95226a1
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY983b3157-cbea-435d-ba32-9ee7ef95226a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-747-3146708074731100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-747-31) 2023-08-08NoNoCurrent
46708-747-91467080747911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-747-91) 2023-08-08NoNoCurrent