Labetalol Hydrochloride

Product NDC
70518-1163
11-digit product format
705181163
Labeler code
70518
Product ID
70518-1163_e314bfc0-9156-0ecd-e053-2a95a90ad774
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207743
Marketing category
ANDA
Marketing start
2018-05-11
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1163-07051811630030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1163-0) 2018-05-110000-00-00NoNoCurrent
70518-1163-170518116301180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1163-1) 2018-07-230000-00-00NoNoCurrent
70518-1163-270518116302180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1163-2) 2021-01-120000-00-00NoNoCurrent