Labetalol Hydrochloride

Product NDC
63629-2054
11-digit product format
636292054
Labeler code
63629
Product ID
63629-2054_a42669d6-2662-4689-bfe7-d8e1034005ad
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
300 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
63629-2054-1Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2054-1EA - Each63629-2054cde7ec8b-8fa5-4d0f-a381-a2640f2e596912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2054LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20230306_b25c0287-1709-4859-93b4-4ea18801d19f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896766labetalol HCl 300 MG Oral TabletPSNb25c0287-1709-4859-93b4-4ea18801d19f102
896766labetalol hydrochloride 300 MG Oral TabletSCDb25c0287-1709-4859-93b4-4ea18801d19f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2054-163629205401100 TABLET, FILM COATED in 1 BOTTLE (63629-2054-1) 2021-01-260000-00-00NoNoCurrent