Levocetirizine Dihydrochloride

Product NDC
42291-386
11-digit product format
422910386
Labeler code
42291
Product ID
42291-386_d57af4f3-6352-5f6c-e053-2995a90a15a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA203646
Marketing category
ANDA
Marketing start
2017-06-16
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-386-90EA - Each42291-38618e08d0d-737a-4b08-92a2-d42a31730d5412017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-386-904229103869090 TABLET in 1 BOTTLE (42291-386-90) 90 tablet2017-06-160000-00-00NoNoCurrent