Cetirizine Hydrochloride

Product NDC
54838-572
11-digit product format
548380572
Labeler code
54838
Product ID
54838-572_083a0699-dc95-44fc-880d-168a6058d0a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA078876
Marketing category
ANDA
Marketing start
2012-05-11
Marketing end
2023-11-30
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-572-40ML - Milliliter54838-5720ff8af1e-f647-4c01-bf03-e8cb7d86398e12015-05-05
54838-572-80ML - Milliliter54838-5726181cb01-3d07-4f56-af10-1f996996ba7112014-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-572-4054838057240120 mL in 1 BOTTLE, PLASTIC (54838-572-40) 120 ml2012-05-112023-11-30NoNoCurrent
54838-572-8054838057280473 mL in 1 BOTTLE, PLASTIC (54838-572-80) 473 ml2012-05-112023-11-30NoNoCurrent