Labetalol HCl

Product NDC
71335-0696
11-digit product format
713350696
Labeler code
71335
Product ID
71335-0696_1cc047f3-b3d9-4782-9964-e05b8f1a4339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075113
Marketing category
ANDA
Marketing start
1998-08-04
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0696-5EA - Each71335-06961eff3792-3806-4f87-a0df-f62b2f0aa08712018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0696-17133506960130 TABLET, FILM COATED in 1 BOTTLE (71335-0696-1) 2018-02-210000-00-00NoNoCurrent
71335-0696-27133506960260 TABLET, FILM COATED in 1 BOTTLE (71335-0696-2) 2018-02-210000-00-00NoNoCurrent
71335-0696-37133506960358 TABLET, FILM COATED in 1 BOTTLE (71335-0696-3) 2018-02-210000-00-00NoNoCurrent
71335-0696-47133506960490 TABLET, FILM COATED in 1 BOTTLE (71335-0696-4) 2018-02-210000-00-00NoNoCurrent
71335-0696-571335069605180 TABLET, FILM COATED in 1 BOTTLE (71335-0696-5) 2018-02-210000-00-00NoNoCurrent