Levocetirizine Dihydrochloride

Product NDC
82804-232
11-digit product format
828040232
Labeler code
82804
Product ID
82804-232_9f83891c-2466-4972-b0f4-b92cc7337be3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090199
Marketing category
ANDA
Marketing start
2011-09-06
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 formatDescriptionMarketing startSampleExclude flagStatus
82804-232-308280402323030 TABLET, FILM COATED in 1 BOTTLE (82804-232-30) 2025-07-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levocetirizine DihydrochlorideProficient Rx LP2025-07-01HUMAN PRESCRIPTION DRUG LABEL1