FDA.reportPublic FDA data

Guanfacine extended-release

Product NDC
70518-4266
11-digit product format
705184266
Labeler code
70518
Product ID
70518-4266_400a2b11-b85e-cbb6-e063-6294a90a5242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205430
Marketing category
ANDA
Marketing start
2025-01-27
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 extended-release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862013

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
70518-4266-0Guanfacine extended-release100 in 1 BOXTABLET, EXTENDED RELEASE1004
70518-4266-1Guanfacine extended-release1 in 1 POUCHTABLET, EXTENDED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4266GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]3Current NDC, 2 package rows20250529_8348e63a-5cbc-489e-b7bf-046c65ba2e8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN8348e63a-5cbc-489e-b7bf-046c65ba2e8e4
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD8348e63a-5cbc-489e-b7bf-046c65ba2e8e4
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY8348e63a-5cbc-489e-b7bf-046c65ba2e8e4
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY8348e63a-5cbc-489e-b7bf-046c65ba2e8e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4266-070518426600100 POUCH in 1 BOX (70518-4266-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4266-1) 100 pouch2025-01-27NoNoHistorical
70518-4266-1705184266011 in 1 POUCHHistorical