Levocetirizine Dihydrochloride

Product NDC
71205-988
11-digit product format
712050988
Labeler code
71205
Product ID
71205-988_7e56c9c2-6e34-4775-bb35-4a70f6189783
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203646
Marketing category
ANDA
Marketing start
2019-09-19
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
71205-988-307120509883030 TABLET in 1 BOTTLE, PLASTIC (71205-988-30) 30 tablet2020-05-01NoNoHistorical
71205-988-607120509886060 TABLET in 1 BOTTLE, PLASTIC (71205-988-60) 60 tablet2020-05-01NoNoHistorical
71205-988-907120509889090 TABLET in 1 BOTTLE, PLASTIC (71205-988-90) 90 tablet2020-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levocetirizine DihydrochlorideProficient Rx LP2022-03-01HUMAN PRESCRIPTION DRUG LABEL3