Labetalol HCL

Product NDC
63629-2215
11-digit product format
636292215
Labeler code
63629
Product ID
63629-2215_220365b9-c7a1-4f6f-a823-2a0f7aaedeaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200908
Marketing category
ANDA
Marketing start
2012-07-24
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
63629-2215-1EA - Each63629-221544d9a1c0-4f4c-4b40-b49b-61e08a1b650712021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2215-163629221501100 TABLET, FILM COATED in 1 BOTTLE (63629-2215-1) 2021-02-080000-00-00NoNoCurrent