Labetalol Hydrochloride

Product NDC
71335-0118
11-digit product format
713350118
Labeler code
71335
Product ID
71335-0118_e29c14b8-2839-4dce-b9a8-1d80871848e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
labetalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018716
Marketing category
NDA
Marketing start
2014-12-01
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
71335-0118-1EA - Each71335-01189de69d63-3dec-4a5f-96d9-d8f1014da9e512018-03-08
71335-0118-2EA - Each71335-01186a36d13e-d248-421a-a4bc-78ef5b032d1512018-03-08
71335-0118-3EA - Each71335-01188a929435-067b-46e1-8584-5b2a6711772f12018-03-08
71335-0118-4EA - Each71335-01182b148b9f-47d2-459a-a517-f6ea57d6868412018-03-08
71335-0118-5EA - Each71335-0118d7ddcd2b-0d59-4e63-be0e-a6aa51570f5912018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0118-17133501180130 TABLET in 1 BOTTLE (71335-0118-1) 30 tablet2015-04-290000-00-00NoNoCurrent
71335-0118-27133501180260 TABLET in 1 BOTTLE (71335-0118-2) 60 tablet2015-04-290000-00-00NoNoCurrent
71335-0118-37133501180358 TABLET in 1 BOTTLE (71335-0118-3) 58 tablet2015-04-290000-00-00NoNoCurrent
71335-0118-47133501180490 TABLET in 1 BOTTLE (71335-0118-4) 90 tablet2015-04-290000-00-00NoNoCurrent
71335-0118-571335011805180 TABLET in 1 BOTTLE (71335-0118-5) 180 tablet2015-04-290000-00-00NoNoCurrent