Labetalol Hydrochloride

Product NDC
47781-554
11-digit product format
477810554
Labeler code
47781
Product ID
47781-554_7f45f847-7bbe-326f-c85a-982ea657bee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
labetalol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alvogen Inc.
Application
NDA018716
Marketing category
NDA
Marketing start
2018-03-01
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
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
47781-554-01EA - Each47781-554065e716a-c4a1-4624-9a14-5e406f0d106712018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-554-0147781055401100 TABLET, FILM COATED in 1 BOTTLE (47781-554-01) 2018-03-010000-00-00NoNoCurrent