Labetalol Hydrochloride

Product NDC
50090-3584
11-digit product format
500903584
Labeler code
50090
Product ID
50090-3584_f6dd6ce7-3554-4ea6-a9e5-c415a60d34f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
labetalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018716
Marketing category
NDA
Marketing start
2014-12-01
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3584-02023-01-30C16284748780-1f386c649-ebb2-0266-e053-dadaa90a7c1aLabetalol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3584-0Labetalol Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3584LABETALOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190531_b3752f70-9972-4327-9ca6-882da762acb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSNb3752f70-9972-4327-9ca6-882da762acb32
896758labetalol hydrochloride 100 MG Oral TabletSCDb3752f70-9972-4327-9ca6-882da762acb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3584-05009035840060 TABLET in 1 BOTTLE (50090-3584-0) 60 tablet2018-09-210000-00-00NoNoCurrent