Levocetirizine Dihydrochloride

Product NDC
70518-2797
11-digit product format
705182797
Labeler code
70518
Product ID
70518-2797_d723421a-66b4-3991-e053-2995a90a413f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202046
Marketing category
ANDA
Marketing start
2020-06-24
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
70518-2797-02022-02-04C16284748780-1d6a99b39-92f6-a426-e053-dadaa90af4c2ff379f83-00a5-418a-a150-75ada91a3ad6
70518-2797-02022-01-28C16284748780-1d6a99b39-92f6-a426-e053-dadaa90af4c2ff379f83-00a5-418a-a150-75ada91a3ad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2797-07051827970030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2797-0) 2020-06-240000-00-00NoNoCurrent