FDA.reportPublic FDA data

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
63868-964
11-digit product format
638680964
Labeler code
63868
Product ID
63868-964_18f49be0-7363-4791-8e46-ffc2a11e7286
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA090922
Marketing category
ANDA
Marketing start
2016-03-03
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; 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
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
63868-964-242020-01-31C16284748780-19d75b9d0-6d75-f424-e053-dadaa90a57ceCetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-964-24Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE42
63868-964-73Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-964CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Legacy NDC, 2 package rows20160629_b83d0d38-442c-41ee-88c3-51690edbcd91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNb83d0d38-442c-41ee-88c3-51690edbcd912
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDb83d0d38-442c-41ee-88c3-51690edbcd912
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYb83d0d38-442c-41ee-88c3-51690edbcd912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-964-24638680964244 in 1 CARTONHistorical
63868-964-73638680964736 in 1 BLISTER PACKHistorical