Guanfacine Hydrochloride

Product NDC
68071-2719
11-digit product format
680712719
Labeler code
68071
Product ID
68071-2719_df759eba-05c2-1923-e053-2a95a90a6b23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214689
Marketing category
ANDA
Marketing start
2021-03-03
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
68071-2719-62025-01-30C16284748780-12cef2736-7a69-d83d-e063-dadaa90ab31fGuanfacine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2719-6Guanfacine Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2719GUANFACINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220521_df759eba-05c1-1923-e053-2a95a90a6b23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSNdf759eba-05c1-1923-e053-2a95a90a6b231
197745guanfacine 1 MG Oral TabletSCDdf759eba-05c1-1923-e053-2a95a90a6b231
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSYdf759eba-05c1-1923-e053-2a95a90a6b231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2719-66807127190660 TABLET in 1 BOTTLE (68071-2719-6) 60 tablet2022-05-200000-00-00NoNoCurrent