Labetalol Hydrochloride

Product NDC
63629-8899
11-digit product format
636298899
Labeler code
63629
Product ID
63629-8899_459f71e2-e307-4195-9622-11f7648c7763
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
63629-8899-1EA - Each63629-88999048b536-af7c-43fd-87b4-3f1a8042bd2d12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8899LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Legacy NDC20240113_7e4f0cf0-946a-4d5f-beb9-28da8a6e46d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8899-163629889901500 TABLET, FILM COATED in 1 BOTTLE (63629-8899-1) 2021-11-190000-00-00NoNoCurrent