Labetalol hydrochloride

Product NDC
50090-7156
11-digit product format
500907156
Labeler code
50090
Product ID
50090-7156_600f7629-8912-496d-872b-753dcdea425a
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
300 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
50090-7156-050090715600100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-0) 2024-04-30NoNoHistorical
50090-7156-15009071560190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-1) 2024-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx OnlyA-S Medication Solutions2024-05-01HUMAN PRESCRIPTION DRUG LABEL1