FDA.reportPublic FDA data

allergy relief

Product NDC
0363-4101
11-digit product format
003634101
Labeler code
0363
Product ID
0363-4101_28f9d48e-60ee-4d58-af55-0b6206044e31
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA078336
Marketing category
ANDA
Marketing start
2021-10-21
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

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
0363-4101-13allergy relief5 in 1 CARTONTABLET, FILM COATED56
0363-4101-13allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED16
0363-4101-39allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-39allergy relief30 in 1 BOTTLETABLET, FILM COATED306
0363-4101-47allergy relief150 in 1 BOTTLETABLET, FILM COATED1506
0363-4101-47allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-58allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-58allergy relief40 in 1 BOTTLETABLET, FILM COATED406
0363-4101-66allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED16
0363-4101-66allergy relief14 in 1 CARTONTABLET, FILM COATED146
0363-4101-72allergy relief60 in 1 BOTTLETABLET, FILM COATED606
0363-4101-72allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-75allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-75allergy relief90 in 1 BOTTLETABLET, FILM COATED906
0363-4101-88allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-88allergy relief365 in 1 BOTTLETABLET, FILM COATED3656
0363-4101-95allergy relief1 in 1 CARTONTABLET, FILM COATED16
0363-4101-95allergy relief45 in 1 BOTTLETABLET, FILM COATED456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4101ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]5Current NDC, Legacy NDC, 18 package rows20241215_678dcc09-55da-4d9d-a39a-c450c61c387b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN678dcc09-55da-4d9d-a39a-c450c61c387b6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD678dcc09-55da-4d9d-a39a-c450c61c387b6
1014678cetirizine HCl 10 MG Oral TabletSY678dcc09-55da-4d9d-a39a-c450c61c387b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4101-13003634101135 BLISTER PACK in 1 CARTON (0363-4101-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2022-03-300000-00-00NoNoCurrent
0363-4101-39003634101391 BOTTLE in 1 CARTON (0363-4101-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-060000-00-00NoNoCurrent
0363-4101-47003634101471 BOTTLE in 1 CARTON (0363-4101-47) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-02NoNoCurrent
0363-4101-58003634101581 BOTTLE in 1 CARTON (0363-4101-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-12-13NoNoCurrent
0363-4101-66003634101661 in 1 BLISTER PACKHistorical
0363-4101-72003634101721 BOTTLE in 1 CARTON (0363-4101-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-17NoNoCurrent
0363-4101-75003634101751 BOTTLE in 1 CARTON (0363-4101-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-10-210000-00-00NoNoCurrent
0363-4101-88003634101881 BOTTLE in 1 CARTON (0363-4101-88) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-03-080000-00-00NoNoCurrent
0363-4101-95003634101951 BOTTLE in 1 CARTON (0363-4101-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-03-25NoNoCurrent