FDA.reportPublic FDA data

WAL ZYR D

Product NDC
0363-1147
11-digit product format
003631147
Labeler code
0363
Product ID
0363-1147_c73e13a0-6791-48ac-b158-4b5e72c7a837
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA210719
Marketing category
ANDA
Marketing start
2020-03-26
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
0363-1147-532025-01-30C16284748780-12cef2736-8fba-d83d-e063-dadaa90ab31fWalgreen Co. Wal-Zyr ™ D Drug Facts
0363-1147-622025-01-30C16284748780-12cef2736-8fba-d83d-e063-dadaa90ab31fWalgreen Co. Wal-Zyr ™ D Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1147-53WAL ZYR D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
0363-1147-53WAL ZYR D12 in 1 CARTONTABLET, FILM COATED, EXTENDED RE123
0363-1147-62WAL ZYR D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
0363-1147-62WAL ZYR D24 in 1 CARTONTABLET, FILM COATED, EXTENDED RE243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1147WAL ZYR D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WALGREEN COMPANY]3Legacy NDC, 4 package rows20231121_f1448ef3-64fd-491f-a79d-cb974fc669c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNf1448ef3-64fd-491f-a79d-cb974fc669c63
1014580WAL-ZYR D ALLERGY & CONGESTION 5 MG / 120 MG 12HR Extended Release Oral TabletPSNf1448ef3-64fd-491f-a79d-cb974fc669c63
101458012 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Wal Zyr D]SBDf1448ef3-64fd-491f-a79d-cb974fc669c63
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDf1448ef3-64fd-491f-a79d-cb974fc669c63
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYf1448ef3-64fd-491f-a79d-cb974fc669c63
1014580Wal Zyr D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral TabletSYf1448ef3-64fd-491f-a79d-cb974fc669c63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1147-530036311475312 BLISTER PACK in 1 CARTON (0363-1147-53) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK12 blister pack2020-03-260000-00-00NoNoCurrent
0363-1147-620036311476224 BLISTER PACK in 1 CARTON (0363-1147-62) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2020-03-260000-00-00NoNoCurrent