FDA.reportPublic FDA data

Labetalol

Product NDC
10135-642
11-digit product format
101350642
Labeler code
10135
Product ID
10135-642_d283e94b-266e-40c6-bee9-856ce2d6ceb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA075215
Marketing category
ANDA
Marketing start
2018-04-01
Marketing end
0000-00-00
Substance
LABETALOL
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
10135-642-012020-01-31C16284748780-19d75b9d0-50d4-f424-e053-dadaa90a57ceLabetalol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-642-01Labetalol100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-642-01EA - Each10135-642af4c881d-29e6-4d53-912f-8e6c4cbe337912018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-642LABETALOL TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20180405_b4c13317-88eb-48f2-aba2-50f01c8ff938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSNb4c13317-88eb-48f2-aba2-50f01c8ff9381
896762labetalol HCl 200 MG Oral TabletPSNb4c13317-88eb-48f2-aba2-50f01c8ff9381
896766labetalol HCl 300 MG Oral TabletPSNb4c13317-88eb-48f2-aba2-50f01c8ff9381
896758labetalol hydrochloride 100 MG Oral TabletSCDb4c13317-88eb-48f2-aba2-50f01c8ff9381
896762labetalol hydrochloride 200 MG Oral TabletSCDb4c13317-88eb-48f2-aba2-50f01c8ff9381
896766labetalol hydrochloride 300 MG Oral TabletSCDb4c13317-88eb-48f2-aba2-50f01c8ff9381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-642-0110135064201100 in 1 BOTTLE, PLASTICHistorical