FDA.reportPublic FDA data

Labetalol HCL

Product NDC
71335-2145
11-digit product format
713352145
Labeler code
71335
Product ID
71335-2145_e7af8ed0-5c0d-4a24-a4cc-8bcc1e1ee672
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
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui896758

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
71335-2145-1Labetalol HCL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30102
71335-2145-2Labetalol HCL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90102
71335-2145-3Labetalol HCL60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60102
71335-2145-4Labetalol HCL120 in 1 BOTTLE, PLASTICTABLET, FILM COATED120102
71335-2145-5Labetalol HCL10 in 1 BOTTLE, PLASTICTABLET, FILM COATED10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2145LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20241019_f1f28e7a-048c-436b-8901-7072ac1d81b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSNf1f28e7a-048c-436b-8901-7072ac1d81b7102
896758labetalol hydrochloride 100 MG Oral TabletSCDf1f28e7a-048c-436b-8901-7072ac1d81b7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2145-17133521450130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-1) 2024-10-040000-00-00NoNoCurrent
71335-2145-27133521450290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-2) 2022-08-180000-00-00NoNoCurrent
71335-2145-37133521450360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-3) 2024-10-040000-00-00NoNoCurrent
71335-2145-471335214504120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-4) 2024-10-040000-00-00NoNoCurrent
71335-2145-57133521450510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2145-5) 2024-10-040000-00-00NoNoCurrent