Labetalol HCL

Product NDC
70518-1546
11-digit product format
705181546
Labeler code
70518
Product ID
70518-1546_e56b775c-e069-f526-e053-2995a90aa9b5
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
2018-10-17
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1546-07051815460030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1546-0) 2018-10-170000-00-00NoNoCurrent
70518-1546-17051815460130 TABLET, FILM COATED in 1 BLISTER PACK (70518-1546-1) 2021-06-030000-00-00NoNoCurrent