allergy relief

Product NDC
0363-3901
11-digit product format
003633901
Labeler code
0363
Product ID
0363-3901_9f9913a7-9054-4d73-b480-e9a5f6446373
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA211983
Marketing category
ANDA
Marketing start
2021-09-23
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 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
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3901-01allergy relief1 in 1 CARTONTABLET, FILM COATED13
0363-3901-01allergy relief35 in 1 BOTTLETABLET, FILM COATED353
0363-3901-27allergy relief80 in 1 BOTTLETABLET, FILM COATED803
0363-3901-27allergy relief1 in 1 CARTONTABLET, FILM COATED13
0363-3901-76allergy relief120 in 1 BOTTLETABLET, FILM COATED1203
0363-3901-76allergy relief1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3901ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]2Current NDC, Legacy NDC, 6 package rows20211001_5033f8e3-c1c4-44e9-a774-703d9b04e82c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN5033f8e3-c1c4-44e9-a774-703d9b04e82c3
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD5033f8e3-c1c4-44e9-a774-703d9b04e82c3
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY5033f8e3-c1c4-44e9-a774-703d9b04e82c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3901-01003633901011 BOTTLE in 1 CARTON (0363-3901-01) / 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-230000-00-00NoNoCurrent
0363-3901-27003633901271 BOTTLE in 1 CARTON (0363-3901-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-230000-00-00NoNoCurrent
0363-3901-76003633901761 BOTTLE in 1 CARTON (0363-3901-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-230000-00-00NoNoCurrent