Labetalol HCL

Product NDC
70934-913
11-digit product format
709340913
Labeler code
70934
Product ID
70934-913_ce3cb14f-cb13-f6e1-e053-2a95a90a9aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA200908
Marketing category
ANDA
Marketing start
2021-10-12
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
70934-913-607093409136060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-913-60) 2021-10-120000-00-00NoNoCurrent