FDA.reportPublic FDA data

LABETALOL HYDROCHLORIDE

Product NDC
72888-122
11-digit product format
728880122
Labeler code
72888
Product ID
72888-122_4e76bf70-d160-7cdd-e063-6294a90a3b7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA211953
Marketing category
ANDA
Marketing start
2021-08-18
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
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
LABETALOL HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-122-01LABETALOL HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004
72888-122-05LABETALOL HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-122-01EA - Each72888-122edbaea4d-86dd-469c-80ff-2d21b3eabc1d12021-12-08
72888-122-05EA - Each72888-122473f2067-2dbf-45dd-b044-5e10906aba6012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-122LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LTD]1Current NDC, Legacy NDC, 2 package rows20211104_1c680447-b43a-4ff1-bc64-2c2174ca1c9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN1c680447-b43a-4ff1-bc64-2c2174ca1c9a4
896762labetalol HCl 200 MG Oral TabletPSN1c680447-b43a-4ff1-bc64-2c2174ca1c9a4
896766labetalol HCl 300 MG Oral TabletPSN1c680447-b43a-4ff1-bc64-2c2174ca1c9a4
896758labetalol hydrochloride 100 MG Oral TabletSCD1c680447-b43a-4ff1-bc64-2c2174ca1c9a4
896762labetalol hydrochloride 200 MG Oral TabletSCD1c680447-b43a-4ff1-bc64-2c2174ca1c9a4
896766labetalol hydrochloride 300 MG Oral TabletSCD1c680447-b43a-4ff1-bc64-2c2174ca1c9a4
896766labetalol HCl 300 MG Oral TabletPSN266e3af5-edd9-5854-e063-6294a90ae1131
896766labetalol HCl 300 MG Oral TabletPSNfffb7c59-ad92-4e74-850d-d94d42b7fdc91
896766labetalol hydrochloride 300 MG Oral TabletSCD266e3af5-edd9-5854-e063-6294a90ae1131
896766labetalol hydrochloride 300 MG Oral TabletSCDfffb7c59-ad92-4e74-850d-d94d42b7fdc91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-122-0172888012201100 TABLET, FILM COATED in 1 BOTTLE (72888-122-01) 2021-08-180000-00-00NoNoCurrent
72888-122-0572888012205500 TABLET, FILM COATED in 1 BOTTLE (72888-122-05) 2021-08-180000-00-00NoNoCurrent