FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
10135-713
11-digit product format
101350713
Labeler code
10135
Product ID
10135-713_23e98950-6176-fa93-e063-6294a90a60a9
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
2020-10-01
Substance
LABETALOL
Active strength
300 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Labetalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR5H8897N95
Rxcui896758, 896762, 896766

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
10135-713-012022-08-30C16284748780-1d6a99b39-e586-a426-e053-dadaa90af4c2Labetalol Hydrochloride Tablets
10135-713-052022-08-30C16284748780-1d6a99b39-e586-a426-e053-dadaa90af4c2Labetalol Hydrochloride Tablets
10135-713-012022-01-28C16284748780-1d6a99b39-e586-a426-e053-dadaa90af4c2Labetalol Hydrochloride Tablets
10135-713-052022-01-28C16284748780-1d6a99b39-e586-a426-e053-dadaa90af4c2Labetalol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-713-01Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
10135-713-05Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-713-01EA - Each10135-7132dffc426-58fe-44cc-bdeb-5cdac8ad705412022-10-06
10135-713-05EA - Each10135-7137a8a93df-18b7-4baa-9fb5-dda42d620ab112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-713LABETALOL HYDROCHLORIDE (LABETALOL) TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 2 package rows20241009_28c91727-e5a8-48b3-a4df-d7bec8feda40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN28c91727-e5a8-48b3-a4df-d7bec8feda405
896762labetalol HCl 200 MG Oral TabletPSN28c91727-e5a8-48b3-a4df-d7bec8feda405
896766labetalol HCl 300 MG Oral TabletPSN28c91727-e5a8-48b3-a4df-d7bec8feda405
896758labetalol hydrochloride 100 MG Oral TabletSCD28c91727-e5a8-48b3-a4df-d7bec8feda405
896762labetalol hydrochloride 200 MG Oral TabletSCD28c91727-e5a8-48b3-a4df-d7bec8feda405
896766labetalol hydrochloride 300 MG Oral TabletSCD28c91727-e5a8-48b3-a4df-d7bec8feda405

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-713-0110135071301100 TABLET, FILM COATED in 1 BOTTLE (10135-713-01) 2020-10-010000-00-00NoNoCurrent
10135-713-0510135071305500 TABLET, FILM COATED in 1 BOTTLE (10135-713-05) 2020-10-010000-00-00NoNoCurrent