Levocetirizine Dihydrochloride

Product NDC
68071-3726
11-digit product format
680713726
Labeler code
68071
Product ID
68071-3726_27878da9-3e05-df72-e063-6394a90a378b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
68071-3726-96807137260990 TABLET, FILM COATED in 1 BOTTLE (68071-3726-9) 2024-11-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levocetirizine DihydrochlorideNuCare Pharmaceuticals, Inc.2024-11-22HUMAN PRESCRIPTION DRUG LABEL1