Allergy Relief

Product NDC
68998-194
11-digit product format
689980194
Labeler code
68998
Product ID
68998-194_ea60a2f4-2e8f-c1f1-e053-2a95a90a286a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-03-01
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
68998-194-02Allergy Relief1 in 1 CARTONTABLET, COATED13
68998-194-02Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED303
68998-194-07Allergy Relief1 in 1 CARTONTABLET, COATED13
68998-194-07Allergy Relief90 in 1 BOTTLE, PLASTICTABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [MARC GLASSMAN, INC.]3Current NDC, Legacy NDC, 4 package rows20221007_951b6f19-15fe-45d7-e053-2995a90aa254.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN951b6f19-15fe-45d7-e053-2995a90aa2543
1014678cetirizine hydrochloride 10 MG Oral TabletSCD951b6f19-15fe-45d7-e053-2995a90aa2543
1014678cetirizine HCl 10 MG Oral TabletSY951b6f19-15fe-45d7-e053-2995a90aa2543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68998-194-02689980194021 BOTTLE, PLASTIC in 1 CARTON (68998-194-02) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2020-03-010000-00-00NoNoCurrent
68998-194-07689980194071 BOTTLE, PLASTIC in 1 CARTON (68998-194-07) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2022-10-050000-00-00NoNoCurrent