Labetalol Hydrochloride

Product NDC
47781-552
11-digit product format
477810552
Labeler code
47781
Product ID
47781-552_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
100 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-552-01EA - Each47781-5521a3bd135-b2f9-42d8-8384-db26f4e005b512018-12-13
47781-552-05EA - Each47781-5520c82bccb-f7e1-4e65-8ee9-ac6d50d579c712019-09-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf4
896758labetalol hydrochloride 100 MG Oral TabletSCD23b3a6a8-b53e-46a1-ad2f-8a33e1c22fcf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-552-0147781055201100 TABLET, FILM COATED in 1 BOTTLE (47781-552-01) 2018-03-010000-00-00NoNoCurrent
47781-552-0547781055205500 TABLET, FILM COATED in 1 BOTTLE (47781-552-05) 2018-03-010000-00-00NoNoCurrent