cetirizine hydrochloride

Product NDC
62011-0414
11-digit product format
620110414
Labeler code
62011
Product ID
62011-0414_8d9819f5-2652-d4ce-3972-027929fb025b
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
2019-11-12
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
62011-0414-1EA - Each62011-0414ddf0f908-7456-4e65-b163-aa5157cbedb512021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0414CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]5Legacy NDC20241025_00b01fa8-2533-ff93-bd13-ca472c46bb94.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0414-1620110414011 BOTTLE in 1 CARTON (62011-0414-1) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-120000-00-00NoNoCurrent
62011-0414-2620110414021 BOTTLE in 1 CARTON (62011-0414-2) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-120000-00-00NoNoCurrent
62011-0414-3620110414031 BOTTLE in 1 CARTON (62011-0414-3) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-120000-00-00NoNoCurrent