Levocetirizine Dihydrochloride

Product NDC
72789-023
11-digit product format
727890023
Labeler code
72789
Product ID
72789-023_2d58a1fb-47b6-e4c8-e063-6294a90ad5f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091264
Marketing category
ANDA
Marketing start
2012-06-29
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SOD6A38AGALEVOCETIRIZINE DIHYDROCHLORIDE130018-87-0LEVOCETIRIZINE DIHYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-023-307278900233030 TABLET in 1 BOTTLE, PLASTIC (72789-023-30) 30 tablet2019-10-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.2025-02-04HUMAN PRESCRIPTION DRUG LABEL13