Labetalol HCL

Product NDC
70518-3411
11-digit product format
705183411
Labeler code
70518
Product ID
70518-3411_dcb0f0e5-a386-6bff-e053-2995a90a2a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200908
Marketing category
ANDA
Marketing start
2022-04-14
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3411-070518341100180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3411-0) 2022-04-140000-00-00NoNoCurrent