FDA.reportPublic FDA data

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
68258-8907
11-digit product format
682588907
Labeler code
68258
Product ID
68258-8907_2f0453e0-6c62-4ee0-94d8-5c354adb562d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl, Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
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
E
Listing certified through
2017-12-31
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
68258-8907-22019-11-27C16284748780-19855d018-ed62-cd31-e053-dbdaa90ab51aPerrigo Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-8907-2Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE62
68258-8907-2Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride4 in 1 CARTONTABLET, EXTENDED RELEASE42

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-8907CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20130718_89d33c73-ad56-43e1-b1a8-8bd98699c31d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN89d33c73-ad56-43e1-b1a8-8bd98699c31d2
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD89d33c73-ad56-43e1-b1a8-8bd98699c31d2
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY89d33c73-ad56-43e1-b1a8-8bd98699c31d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-8907-2682588907026 in 1 BLISTER PACKHistorical