Labetalol Hydrochloride

Product NDC
63629-8902
11-digit product format
636298902
Labeler code
63629
Product ID
63629-8902_c59ea3f8-94c3-466c-88ce-1363cf9d6b15
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
300 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
63629-8902-1EA - Each63629-8902b9044f43-4565-4390-99ec-5416ed3bab8312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8902LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Legacy NDC20240113_20ecac3e-1f33-48a5-b069-c794c8e11cf8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8902-163629890201100 TABLET, FILM COATED in 1 BOTTLE (63629-8902-1) 2021-11-190000-00-00NoNoCurrent