Allergy Relief

Product NDC
68210-4159
11-digit product format
682104159
Labeler code
68210
Product ID
68210-4159_4949097a-aedb-eb3c-e063-6294a90a1192
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prodose, Inc
Application
ANDA077829
Marketing category
ANDA
Marketing start
2021-04-28
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
Allergy Relief
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
68210-4159-1Allergy Relief1 in 1 CARTONTABLET, FILM COATED16
68210-4159-1Allergy Relief14 in 1 BLISTER PACKTABLET, FILM COATED146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4159ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]5Current NDC, Legacy NDC, 2 package rows20250101_e0e5f482-0282-410c-8c40-0a33ca4ea23a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNe0e5f482-0282-410c-8c40-0a33ca4ea23a6
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe0e5f482-0282-410c-8c40-0a33ca4ea23a6
1014678cetirizine HCl 10 MG Oral TabletSYe0e5f482-0282-410c-8c40-0a33ca4ea23a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4159-1682104159011 BLISTER PACK in 1 CARTON (68210-4159-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-05-260000-00-00NoNoCurrent