Exchange select all day allergy

Product NDC
55301-076
11-digit product format
553010076
Labeler code
55301
Product ID
55301-076_e61a6e00-ceae-4a3b-bbf8-ead4edc14d59
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Army & Air Force Exchange Service
Application
ANDA078336
Marketing category
ANDA
Marketing start
2016-05-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Exchange select all day allergy
Listing expiration
2027-12-31

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
55301-076-39Exchange select all day allergy30 in 1 BOTTLETABLET, FILM COATED305
55301-076-39Exchange select all day allergy1 in 1 CARTONTABLET, FILM COATED15
55301-076-95Exchange select all day allergy45 in 1 BOTTLETABLET, FILM COATED455
55301-076-95Exchange select all day allergy1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-076EXCHANGE SELECT ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [ARMY & AIR FORCE EXCHANGE SERVICE]4Current NDC, Legacy NDC, 4 package rows20201008_e7220494-3640-4b33-b577-ed3ca7c483e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNe7220494-3640-4b33-b577-ed3ca7c483e85
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe7220494-3640-4b33-b577-ed3ca7c483e85
1014678cetirizine HCl 10 MG Oral TabletSYe7220494-3640-4b33-b577-ed3ca7c483e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-076-39553010076391 BOTTLE in 1 CARTON (55301-076-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-08-290000-00-00NoNoCurrent
55301-076-95553010076951 BOTTLE in 1 CARTON (55301-076-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-05-130000-00-00NoNoCurrent