FDA.reportPublic FDA data

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
50090-1098
11-digit product format
500901098
Labeler code
50090
Product ID
50090-1098_b1c8e625-3895-4891-ab88-03d43b3785b5
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl, Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077170
Marketing category
ANDA
Marketing start
2008-04-10
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1098-02023-01-30C16284748780-1f386c649-ca9b-0266-e053-dadaa90a7c1aPerrigo Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Drug Facts
50090-1098-12023-01-30C16284748780-1f386c649-ca9b-0266-e053-dadaa90a7c1aPerrigo Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1098-0Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE309
50090-1098-1Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride24 in 1 CARTONTABLET, EXTENDED RELEASE249
50090-1098-1Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1098-1EA - Each50090-1098ef685bcb-68ed-489a-bf74-ccdaf3dbf88512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1098CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Legacy NDC, 3 package rows20210416_5f854bf4-6c57-4701-869a-6cfd82edcb81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN5f854bf4-6c57-4701-869a-6cfd82edcb819
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD5f854bf4-6c57-4701-869a-6cfd82edcb819
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY5f854bf4-6c57-4701-869a-6cfd82edcb819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1098-05009010980030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-1098-0) 2019-10-090000-00-00NoNoCurrent
50090-1098-15009010980124 BLISTER PACK in 1 CARTON (50090-1098-1) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2014-11-280000-00-00NoNoCurrent