Cetirizine Hydrochloride

Product NDC
63187-932
11-digit product format
631870932
Labeler code
63187
Product ID
63187-932_78af6245-731f-4845-b844-6ad94bacfea5
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078317
Marketing category
ANDA
Marketing start
2007-12-27
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-932-15EA - Each63187-9326ef956a1-b1f5-4ac9-8b3b-24bc62ba66cb12018-02-20
63187-932-30EA - Each63187-9328f9cbe54-bbfa-49b3-988e-dc93a4ece7d112018-02-20
63187-932-90EA - Each63187-932820475d4-0952-47c0-a018-d7d66df3500112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-932CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]4Legacy NDC20191108_06e0ddde-cd4c-47b0-80eb-d9bc853e0d4f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-932-156318709321515 TABLET, FILM COATED in 1 BOTTLE (63187-932-15) 2017-12-010000-00-00NoNoCurrent
63187-932-306318709323030 TABLET, FILM COATED in 1 BOTTLE (63187-932-30) 2017-11-010000-00-00NoNoCurrent
63187-932-606318709326060 TABLET, FILM COATED in 1 BOTTLE (63187-932-60) 2017-11-010000-00-00NoNoCurrent
63187-932-906318709329090 TABLET, FILM COATED in 1 BOTTLE (63187-932-90) 2017-11-010000-00-00NoNoCurrent