FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
71335-3065
11-digit product format
713353065
Labeler code
71335
Product ID
71335-3065_4b1e4682-4771-4ac0-afe3-4eaa71130562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075215
Marketing category
ANDA
Marketing start
2019-11-22
Substance
LABETALOL
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Labetalol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR5H8897N95
Rxcui896758

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3065-1Labetalol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71335-3065-2Labetalol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
71335-3065-3Labetalol Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71335-3065-4Labetalol Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
71335-3065-5Labetalol Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSNd8b69cc9-bdee-4e24-a3d8-d1887de5a17d1
896758labetalol hydrochloride 100 MG Oral TabletSCDd8b69cc9-bdee-4e24-a3d8-d1887de5a17d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3065-17133530650130 TABLET, FILM COATED in 1 BOTTLE (71335-3065-1) 2026-02-06NoNoHistorical
71335-3065-27133530650290 TABLET, FILM COATED in 1 BOTTLE (71335-3065-2) 2026-02-06NoNoHistorical
71335-3065-37133530650360 TABLET, FILM COATED in 1 BOTTLE (71335-3065-3) 2026-02-06NoNoHistorical
71335-3065-471335306504120 TABLET, FILM COATED in 1 BOTTLE (71335-3065-4) 2026-02-06NoNoHistorical
71335-3065-57133530650510 TABLET, FILM COATED in 1 BOTTLE (71335-3065-5) 2026-02-06NoNoHistorical