Labetalol hydrochloride

Product NDC
50090-6778
11-digit product format
500906778
Labeler code
50090
Product ID
50090-6778_5482004c-a140-496c-bc1d-ec9cb91926c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075133
Marketing category
ANDA
Marketing start
1998-08-03
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1GEV3BAW9JLABETALOL HYDROCHLORIDE32780-64-6LABETALOL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6778-05009067780090 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0) 2023-10-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx OnlyA-S Medication Solutions2023-10-30HUMAN PRESCRIPTION DRUG LABEL1