FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
50090-3188
11-digit product format
500903188
Labeler code
50090
Product ID
50090-3188_76897354-b74f-4de7-be37-829ce4a4b68e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3188-02023-01-30C16284748780-1f386c64a-37c4-0266-e053-dadaa90a7c1aCetrizine HCL Tablet 10 mg
50090-3188-12023-01-30C16284748780-1f386c64a-37c4-0266-e053-dadaa90a7c1aCetrizine HCL Tablet 10 mg
50090-3188-22023-01-30C16284748780-1f386c64a-37c4-0266-e053-dadaa90a7c1aCetrizine HCL Tablet 10 mg
50090-3188-32023-01-30C16284748780-1f386c64a-37c4-0266-e053-dadaa90a7c1aCetrizine HCL Tablet 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3188-0Cetirizine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED143
50090-3188-1Cetirizine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
50090-3188-2Cetirizine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
50090-3188-3Cetirizine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3188-0EA - Each50090-31889e178ff4-89e5-4402-9a10-5112baeb486812018-12-13
50090-3188-1EA - Each50090-3188f589340d-1209-47e4-97fd-2e4150bc640012019-05-02
50090-3188-2EA - Each50090-31883a1e3a6a-d0e0-49b3-a60a-81bd8c62d05a12019-05-02
50090-3188-3EA - Each50090-3188c529cceb-1ffd-4427-97af-f81a511ee7fc12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3188CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 4 package rows20190427_66e7c776-4ae3-43e0-ac3e-c0bf3ad98795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN66e7c776-4ae3-43e0-ac3e-c0bf3ad987953
1014678cetirizine hydrochloride 10 MG Oral TabletSCD66e7c776-4ae3-43e0-ac3e-c0bf3ad987953
1014678cetirizine HCl 10 MG Oral TabletSY66e7c776-4ae3-43e0-ac3e-c0bf3ad987953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3188-05009031880014 TABLET, FILM COATED in 1 BOTTLE (50090-3188-0) 2017-10-230000-00-00NoNoCurrent
50090-3188-15009031880130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3188-1) 2014-11-280000-00-00NoNoCurrent
50090-3188-250090318802100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3188-2) 2014-11-280000-00-00NoNoCurrent
50090-3188-35009031880390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3188-3) 2014-11-280000-00-00NoNoCurrent