Labetalol Hydrochloride

Product NDC
63629-2055
11-digit product format
636292055
Labeler code
63629
Product ID
63629-2055_ce9867c2-ca9e-4b28-a31f-8b75854ff231
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207863
Marketing category
ANDA
Marketing start
2019-05-24
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
63629-2055-163629205501500 TABLET, FILM COATED in 1 BOTTLE (63629-2055-1) 2021-01-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Labetalol Hydrochloride TabletsBryant Ranch Prepack2023-03-02HUMAN PRESCRIPTION DRUG LABEL102