Wal-Zyr D

Product NDC
0363-0989
11-digit product format
003630989
Labeler code
0363
Product ID
0363-0989_8b190a22-48f3-4ec7-b0de-2879e66e9358
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA090922
Marketing category
ANDA
Marketing start
2018-11-01
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wal-Zyr D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA, 6V9V2RYJ8N
Rxcui1014571, 1014580

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0989-12Wal-Zyr D6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE66
0363-0989-12Wal-Zyr D2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE26
0363-0989-24Wal-Zyr D6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE66
0363-0989-24Wal-Zyr D4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0989-12EA - Each0363-0989f8cf6dac-ed1d-4d09-84e4-f8456a3624a912022-06-06
0363-0989-24EA - Each0363-098913f43468-2e90-4eba-813b-5eecb37e764312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0989WAL-ZYR D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WALGREEN COMPANY]6Current NDC, Legacy NDC, 4 package rows20240130_778ba62e-6cce-4d0f-b6d9-48b35ef40da7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN778ba62e-6cce-4d0f-b6d9-48b35ef40da76
1014580WAL-ZYR D ALLERGY & CONGESTION 5 MG / 120 MG 12HR Extended Release Oral TabletPSN778ba62e-6cce-4d0f-b6d9-48b35ef40da76
101458012 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Wal Zyr D]SBD778ba62e-6cce-4d0f-b6d9-48b35ef40da76
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD778ba62e-6cce-4d0f-b6d9-48b35ef40da76
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY778ba62e-6cce-4d0f-b6d9-48b35ef40da76
1014580Wal Zyr D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral TabletSY778ba62e-6cce-4d0f-b6d9-48b35ef40da76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0989-12003630989122 BLISTER PACK in 1 CARTON (0363-0989-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2018-11-010000-00-00NoNoCurrent
0363-0989-24003630989244 BLISTER PACK in 1 CARTON (0363-0989-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2018-11-010000-00-00NoNoCurrent