Labetalol Hydrochloride

Product NDC
63629-8898
11-digit product format
636298898
Labeler code
63629
Product ID
63629-8898_81d94deb-119e-45e0-8c51-71cbb57efd0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209603
Marketing category
ANDA
Marketing start
2021-05-27
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8898-1EA - Each63629-88985eb3bdc0-5c74-465c-beb4-0088a7e35f2912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8898LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Legacy NDC20240113_1bef976f-00f6-483f-baf0-f8a4139a71c4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8898-163629889801100 TABLET, FILM COATED in 1 BOTTLE (63629-8898-1) 2021-11-190000-00-00NoNoCurrent