Levocetirizine Dihydrochloride

Product NDC
61442-460
11-digit product format
614420460
Labeler code
61442
Product ID
61442-460_2e47680c-c285-02ce-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA203646
Marketing category
ANDA
Marketing start
2015-11-11
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61442-460-902022-03-22C16284748780-19d75b9d0-8afd-f424-e053-dadaa90a57ce6554827e-6aad-43c7-969c-69ef12103ce1
61442-460-902020-01-31C16284748780-19d75b9d0-8afd-f424-e053-dadaa90a57ce6554827e-6aad-43c7-969c-69ef12103ce1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-460-90EA - Each61442-4601e3ab3e8-70aa-44ae-ac49-474e15ed2df612016-02-04