FDA.reportPublic FDA data

Labetalol HCL

Product NDC
71335-1410
11-digit product format
713351410
Labeler code
71335
Product ID
71335-1410_98b598e0-64b7-4a8c-9c7f-a8891fd4e708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200908
Marketing category
ANDA
Marketing start
2012-07-24
Substance
LABETALOL HYDROCHLORIDE
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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui896766

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1410-1Labetalol HCL30 in 1 BOTTLETABLET, FILM COATED306
71335-1410-2Labetalol HCL60 in 1 BOTTLETABLET, FILM COATED606
71335-1410-3Labetalol HCL58 in 1 BOTTLETABLET, FILM COATED586
71335-1410-4Labetalol HCL90 in 1 BOTTLETABLET, FILM COATED906
71335-1410-5Labetalol HCL180 in 1 BOTTLETABLET, FILM COATED1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1410LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20241024_06ff81fe-9226-49a7-aa5c-f52b059d7cab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896766labetalol HCl 300 MG Oral TabletPSN06ff81fe-9226-49a7-aa5c-f52b059d7cab6
896766labetalol hydrochloride 300 MG Oral TabletSCD06ff81fe-9226-49a7-aa5c-f52b059d7cab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1410-17133514100130 TABLET, FILM COATED in 1 BOTTLE (71335-1410-1) 2024-10-070000-00-00NoNoCurrent
71335-1410-27133514100260 TABLET, FILM COATED in 1 BOTTLE (71335-1410-2) 2019-11-270000-00-00NoNoCurrent
71335-1410-37133514100358 TABLET, FILM COATED in 1 BOTTLE (71335-1410-3) 2024-10-070000-00-00NoNoCurrent
71335-1410-47133514100490 TABLET, FILM COATED in 1 BOTTLE (71335-1410-4) 2024-10-070000-00-00NoNoCurrent
71335-1410-571335141005180 TABLET, FILM COATED in 1 BOTTLE (71335-1410-5) 2024-10-070000-00-00NoNoCurrent