Labetalol Hydrochloride

Product NDC
70518-2903
11-digit product format
705182903
Labeler code
70518
Product ID
70518-2903_d7960f82-12bf-f8e9-e053-2995a90a6e91
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
2020-10-08
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2903-02022-02-09C16284748780-1d6a99b39-96a3-a426-e053-dadaa90af4c21e7736f0-1435-470f-8468-2c65d605632e
70518-2903-02022-01-28C16284748780-1d6a99b39-96a3-a426-e053-dadaa90af4c21e7736f0-1435-470f-8468-2c65d605632e

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2903-07051829030030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2903-0) 2020-10-080000-00-00NoNoCurrent