cetirizine hydrochloride

Product NDC
62011-0307
11-digit product format
620110307
Labeler code
62011
Product ID
62011-0307_d0d3df80-edb8-5398-fc66-09d7f5b0662c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA078343
Marketing category
ANDA
Marketing start
2016-09-30
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 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
62011-0307-1EA - Each62011-03070cae432c-2937-4f96-bdc9-b0983191b0d612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0307CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]6Legacy NDC20241025_ecf956da-8ff7-0d69-63c0-2189fb8db295.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0307-1620110307011 BOTTLE in 1 CARTON (62011-0307-1) > 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-300000-00-00NoNoCurrent