FDA.reportPublic FDA data

Guanfacine

Product NDC
70518-2771
11-digit product format
705182771
Labeler code
70518
Product ID
70518-2771_4a8f6fe7-ff80-5bff-e063-6294a90a39ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201408
Marketing category
ANDA
Marketing start
2020-06-08
Substance
GUANFACINE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30OMY4G3MK
Rxcui862006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2771-02022-02-02C16284748780-1d6a99b39-fe95-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 1986
70518-2771-02022-01-28C16284748780-1d6a99b39-fe95-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2771-0GuanfacineExtended-Release30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3013
70518-2771-1GuanfacineExtended-Release100 in 1 BOXTABLET, EXTENDED RELEASE10013
70518-2771-2GuanfacineExtended-Release1 in 1 POUCHTABLET, EXTENDED RELEASE113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2771GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250510_36fd53a6-7006-4955-a3cd-b1c08cf84d6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY36fd53a6-7006-4955-a3cd-b1c08cf84d6c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2771-07051827710030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2771-0) 2020-06-080000-00-00NoNoCurrent
70518-2771-170518277101100 POUCH in 1 BOX (70518-2771-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2771-2) 100 pouch2025-01-27NoNoHistorical
70518-2771-2705182771021 in 1 POUCHHistorical