FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
71335-9690
11-digit product format
713359690
Labeler code
71335
Product ID
71335-9690_b5b49b68-10f1-4022-8ed9-d0d9294628f3
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
300 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
LABETALOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR5H8897N95
Rxcui896766

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
71335-9690-1Labetalol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30103
71335-9690-2Labetalol Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60103
71335-9690-3Labetalol Hydrochloride58 in 1 BOTTLETABLET, FILM COATED58103
71335-9690-4Labetalol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90103
71335-9690-5Labetalol Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9690LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 5 package rows20240406_0db22a64-1863-4188-850b-273ea746e327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896766labetalol HCl 300 MG Oral TabletPSN0db22a64-1863-4188-850b-273ea746e327103
896766labetalol hydrochloride 300 MG Oral TabletSCD0db22a64-1863-4188-850b-273ea746e327103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9690-17133596900130 TABLET, FILM COATED in 1 BOTTLE (71335-9690-1) 2024-04-03NoNoHistorical
71335-9690-27133596900260 TABLET, FILM COATED in 1 BOTTLE (71335-9690-2) 2023-03-21NoNoHistorical
71335-9690-37133596900358 TABLET, FILM COATED in 1 BOTTLE (71335-9690-3) 2024-04-03NoNoHistorical
71335-9690-47133596900490 TABLET, FILM COATED in 1 BOTTLE (71335-9690-4) 2024-04-03NoNoHistorical
71335-9690-571335969005180 TABLET, FILM COATED in 1 BOTTLE (71335-9690-5) 2024-04-03NoNoHistorical