FDA.reportPublic FDA data

LABETALOL HYDROCHLORIDE

Product NDC
72888-121
11-digit product format
728880121
Labeler code
72888
Product ID
72888-121_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
200 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 HYDROCHLORIDE200 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
72888-121-01LABETALOL HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004
72888-121-05LABETALOL HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-121-01EA - Each72888-12129572b4c-a520-4cbe-b990-e6d69d7feb4312021-12-08
72888-121-05EA - Each72888-12104bfc393-6e87-434b-97b9-f10da2689e1912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-121LABETALOL 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
896762labetalol HCl 200 MG Oral TabletPSN04f9dcdf-4023-48ee-9e7d-ca9366d9db72102
896762labetalol hydrochloride 200 MG Oral TabletSCD04f9dcdf-4023-48ee-9e7d-ca9366d9db72102
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
896762labetalol HCl 200 MG Oral TabletPSN1a71964e-e6fa-443e-bfdd-f8852f8cf29e1
896762labetalol HCl 200 MG Oral TabletPSN266d8f32-ae3e-511f-e063-6394a90a49d61
896762labetalol HCl 200 MG Oral TabletPSNe6836a01-220d-4b69-9b4a-c919daeb6ece1
896762labetalol hydrochloride 200 MG Oral TabletSCD1a71964e-e6fa-443e-bfdd-f8852f8cf29e1
896762labetalol hydrochloride 200 MG Oral TabletSCD266d8f32-ae3e-511f-e063-6394a90a49d61
896762labetalol hydrochloride 200 MG Oral TabletSCDe6836a01-220d-4b69-9b4a-c919daeb6ece1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-121-0172888012101100 TABLET, FILM COATED in 1 BOTTLE (72888-121-01) 2021-08-180000-00-00NoNoCurrent
72888-121-0572888012105500 TABLET, FILM COATED in 1 BOTTLE (72888-121-05) 2021-08-180000-00-00NoNoCurrent