Labetalol Hydrochloride

Product NDC
63629-2053
11-digit product format
636292053
Labeler code
63629
Product ID
63629-2053_887d805b-d3d6-4b36-aa21-992df0c0201d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207863
Marketing category
ANDA
Marketing start
2019-05-24
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
2026-12-31
Current FDA listing
Yes

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
63629-2053-1Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2053-1EA - Each63629-2053d12ff554-edb8-49fb-ac55-7d75abb1698912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2053LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20230306_d073b03d-057d-44eb-a3a7-8f439b965c8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896762labetalol HCl 200 MG Oral TabletPSNd073b03d-057d-44eb-a3a7-8f439b965c8a102
896762labetalol hydrochloride 200 MG Oral TabletSCDd073b03d-057d-44eb-a3a7-8f439b965c8a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2053-163629205301500 TABLET, FILM COATED in 1 BOTTLE (63629-2053-1) 2021-02-020000-00-00NoNoCurrent