Labetalol Hydrochloride

Product NDC
70518-2728
11-digit product format
705182728
Labeler code
70518
Product ID
70518-2728_d6e73a52-b72d-3943-e053-2995a90abd39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207863
Marketing category
ANDA
Marketing start
2020-05-05
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2728-02022-01-31C16284748780-1d6a99b39-fc71-a426-e053-dadaa90af4c2f873d533-f4c0-4e23-90f7-dba26ef0e811
70518-2728-02022-01-28C16284748780-1d6a99b39-fc71-a426-e053-dadaa90af4c2f873d533-f4c0-4e23-90f7-dba26ef0e811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2728-07051827280030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2728-0) 2020-05-050000-00-00NoNoCurrent