Allergy Relief

Product NDC
68210-4230
11-digit product format
682104230
Labeler code
68210
Product ID
68210-4230_0bde5cd4-6043-3d42-e063-6394a90ac001
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
ANDA209274
Marketing category
ANDA
Marketing start
2022-11-16
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
68210-4230-1Allergy Relief120 in 1 POUCHTABLET, FILM COATED1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4230ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]3Current NDC, Legacy NDC, 1 package rows20231207_c9eb5102-5514-4e69-8169-be7341e9fb66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNc9eb5102-5514-4e69-8169-be7341e9fb663
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc9eb5102-5514-4e69-8169-be7341e9fb663
1014678cetirizine HCl 10 MG Oral TabletSYc9eb5102-5514-4e69-8169-be7341e9fb663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4230-168210423001120 TABLET, FILM COATED in 1 POUCH (68210-4230-1) 2022-11-160000-00-00NoNoCurrent