Cetirizine Hydrochloride

Product NDC
49348-389
11-digit product format
493480389
Labeler code
49348
Product ID
49348-389_66aefab9-b8cd-4498-a7ae-a10c1719e02e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sunmark
Application
ANDA077498
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-389-132020-01-31C16284748780-19d75b9d1-0b55-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-389-13Cetirizine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-389-13EA - Each49348-3892fe33605-e990-4f4d-a59e-0f4c224fa9b912015-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-389CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [SUNMARK]2Legacy NDC, 1 package rows20130321_3d835abb-fa88-4185-a3c2-212f5cefd57d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3d835abb-fa88-4185-a3c2-212f5cefd57d2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3d835abb-fa88-4185-a3c2-212f5cefd57d2
1014678cetirizine HCl 10 MG Oral TabletSY3d835abb-fa88-4185-a3c2-212f5cefd57d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49348-389-134934803891390 in 1 BOTTLEHistorical