FDA.reportPublic FDA data

Guanfacine

Product NDC
29300-463
11-digit product format
293000463
Labeler code
29300
Product ID
29300-463_02271fb1-d7ad-49cb-a6a4-622e458e5db7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA219033
Marketing category
ANDA
Marketing start
2024-11-19
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
2026-12-31

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
29300-463-01Guanfacine100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-463GUANFACINE TABLET, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, 1 package rows20250403_f4e3c976-8811-4388-92b3-d248d705f8b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSNf4e3c976-8811-4388-92b3-d248d705f8b16
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSNf4e3c976-8811-4388-92b3-d248d705f8b16
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSNf4e3c976-8811-4388-92b3-d248d705f8b16
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSNf4e3c976-8811-4388-92b3-d248d705f8b16
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCDf4e3c976-8811-4388-92b3-d248d705f8b16
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCDf4e3c976-8811-4388-92b3-d248d705f8b16
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCDf4e3c976-8811-4388-92b3-d248d705f8b16
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCDf4e3c976-8811-4388-92b3-d248d705f8b16
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSYf4e3c976-8811-4388-92b3-d248d705f8b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
29300-463-0129300046301100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-463-01) 2025-02-01NoNoCurrent