Labetalol Hydrochloride

Product NDC
47781-553
11-digit product format
477810553
Labeler code
47781
Product ID
47781-553_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
200 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
47781-553-01EA - Each47781-5532edb979b-fb3e-43f7-b98a-625a9dec1a9712018-12-13
47781-553-05EA - Each47781-553c56900ea-4a37-41bd-9578-215ba9f635a112018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-553-0147781055301100 TABLET, FILM COATED in 1 BOTTLE (47781-553-01) 2018-03-010000-00-00NoNoCurrent
47781-553-0547781055305500 TABLET, FILM COATED in 1 BOTTLE (47781-553-05) 2018-03-010000-00-00NoNoCurrent