FDA.reportPublic FDA data

Wal-Zyr

Product NDC
0363-0606
11-digit product format
003630606
Labeler code
0363
Product ID
0363-0606_1302e384-8493-4448-8c99-e382beaa7946
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA209274
Marketing category
ANDA
Marketing start
2018-08-31
Marketing end
2026-12-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wal-Zyr

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678, 1087169

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0606-03Wal-Zyr30 in 1 BOTTLE, PLASTICTABLET306
0363-0606-03Wal-Zyr1 in 1 BOXTABLET16
0363-0606-05Wal-Zyr1 in 1 BLISTER PACKTABLET16
0363-0606-05Wal-Zyr5 in 1 CARTONTABLET56
0363-0606-14Wal-Zyr1 in 1 BLISTER PACKTABLET16
0363-0606-14Wal-Zyr14 in 1 CARTONTABLET146
0363-0606-30Wal-Zyr1 in 1 BOXTABLET16
0363-0606-30Wal-Zyr300 in 1 BOTTLE, PLASTICTABLET3006
0363-0606-45Wal-Zyr1 in 1 BOXTABLET16
0363-0606-45Wal-Zyr45 in 1 BOTTLE, PLASTICTABLET456

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0606-05EA - Each0363-0606ff300e43-ff5a-48f9-9e0f-c03989da539112022-06-06
0363-0606-30EA - Each0363-06064b6fb35c-6e99-4cfe-80bb-c9380554778212019-11-12
0363-0606-45EA - Each0363-060651b50b02-a605-4dbe-8f2f-ec39bb73117a12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0606WAL-ZYR (CETIRIZINE HCL) TABLET [WALGREENS]5Current NDC, Legacy NDC, 10 package rows20220527_f0d3f681-92c4-45d4-9533-656c9e5e2366.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf0d3f681-92c4-45d4-9533-656c9e5e23666
1087169Wal-Zyr All Day Allergy 10 MG 24HR Oral TabletPSNf0d3f681-92c4-45d4-9533-656c9e5e23666
1087169cetirizine hydrochloride 10 MG Oral Tablet [Wal-Zyr]SBDf0d3f681-92c4-45d4-9533-656c9e5e23666
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf0d3f681-92c4-45d4-9533-656c9e5e23666
1014678cetirizine HCl 10 MG Oral TabletSYf0d3f681-92c4-45d4-9533-656c9e5e23666
1087169Wal-Zyr 10 MG Oral TabletSYf0d3f681-92c4-45d4-9533-656c9e5e23666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0606-03003630606031 BOTTLE, PLASTIC in 1 BOX (0363-0606-03) / 30 TABLET in 1 BOTTLE, PLASTIC2018-08-312026-12-31NoNoCurrent
0363-0606-05003630606055 BLISTER PACK in 1 CARTON (0363-0606-05) / 1 TABLET in 1 BLISTER PACK5 blister pack2018-08-312026-12-31NoNoCurrent
0363-0606-140036306061414 BLISTER PACK in 1 CARTON (0363-0606-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2018-08-312026-12-31NoNoCurrent
0363-0606-30003630606301 BOTTLE, PLASTIC in 1 BOX (0363-0606-30) / 300 TABLET in 1 BOTTLE, PLASTIC2018-08-312026-12-31NoNoCurrent
0363-0606-45003630606451 BOTTLE, PLASTIC in 1 BOX (0363-0606-45) / 45 TABLET in 1 BOTTLE, PLASTIC2018-08-312026-12-31NoNoCurrent