Skip to content
LookupMeds

Active ingredient

Labetalol

144 finished FDA listings contain Labetalol as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
LABETALOL, LABETALOL HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution, Tablet, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
45
Strengths listed
1 mg/ml · 100 mg/1 · 100 mg/20ml · 200 mg/1 · 200 mg/40ml · 300 mg/1 · 400 mg/1 · 5 mg/ml
Brand names in FDA listings
Labetalol Hcl, Labetalol Hcl In Dextrose, Labetalol Hcl In Sodium Chloride, Labetalol Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6185

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 074787HERITAGE PHARMA1998-08-0314
ANDA 075133WATSON LABS1998-08-034
ANDA 075303HIKMA1999-05-285
ANDA 075215INNOGENIX1999-07-2928
ANDA 075240HOSPIRA1999-11-291
ANDA 075239HOSPIRA1999-11-292
ANDA 076051BAXTER HLTHCARE CORP2002-07-053
ANDA 079134ONESOURCE SPECIALTY2010-02-032
ANDA 090699GLAND PHARMA LTD2012-04-036
ANDA 200908PH HEALTH2012-07-101
ANDA 207743ZYDUS PHARMS2017-09-1915
ANDA 209603APPCO2018-06-2028
ANDA 211325CADILA PHARMS LTD2019-05-133
ANDA 212990EPIC PHARMA LLC2020-09-303
NDA 213330HIKMA2020-11-095
ANDA 211953RUBICON RESEARCH2021-08-1812
ANDA 214533CAPLIN2021-09-075
ANDA 212719UNICHEM2022-08-083
ANDA 217949MACLEODS PHARMS LTD2025-09-233
ANDA 218870AMNEAL2025-10-021

Official labeling on DailyMed

Showing the 12 most recent of 83 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.