Labetalol Hydrochloride

Product NDC
50090-4149
11-digit product format
500904149
Labeler code
50090
Product ID
50090-4149_7164c86a-8886-404a-924f-af4b75dc28e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
labetalol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018716
Marketing category
NDA
Marketing start
2018-03-01
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
2022-12-31
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
50090-4149-02023-01-30C16284748780-1f386c649-d300-0266-e053-dadaa90a7c1aLabetalol Hydrochloride Tablets
50090-4149-12023-01-30C16284748780-1f386c649-d300-0266-e053-dadaa90a7c1aLabetalol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4149-0Labetalol Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
50090-4149-1Labetalol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4149-0EA - Each50090-41499050d60b-6ea7-4af9-8726-fc8f761181da12022-01-06
50090-4149-1EA - Each50090-4149d5beb324-eb5a-47a9-8e7d-69d243609fc212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4149LABETALOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20210303_23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf4
896758labetalol hydrochloride 100 MG Oral TabletSCD23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4149-05009041490060 TABLET, FILM COATED in 1 BOTTLE (50090-4149-0) 2019-02-200000-00-00NoNoCurrent
50090-4149-15009041490190 TABLET, FILM COATED in 1 BOTTLE (50090-4149-1) 2019-02-200000-00-00NoNoCurrent