FDA.reportPublic FDA data

Allergy Relief

Product NDC
68016-294
11-digit product format
680160294
Labeler code
68016
Product ID
68016-294_24340f37-44e4-b094-e063-6294a90a7886
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG CONSORTIUM
Application
ANDA209274
Marketing category
ANDA
Marketing start
2019-11-01
Marketing end
2026-07-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief

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
68016-294-14Allergy Relief14 in 1 BOTTLE, PLASTICTABLET, COATED143
68016-294-14Allergy Relief1 in 1 CARTONTABLET, COATED13
68016-294-30Allergy Relief1 in 1 CARTONTABLET, COATED13
68016-294-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED303
68016-294-60Allergy Relief60 in 1 BOTTLE, PLASTICTABLET, COATED603
68016-294-60Allergy Relief1 in 1 CARTONTABLET, COATED13
68016-294-90Allergy Relief1 in 1 CARTONTABLET, COATED13
68016-294-90Allergy Relief90 in 1 BOTTLE, PLASTICTABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-294ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG CONSORTIUM]3Current NDC, Legacy NDC, 8 package rows20241013_5e0ef968-dff3-4446-8412-8085677332f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN5e0ef968-dff3-4446-8412-8085677332f03
1014678cetirizine hydrochloride 10 MG Oral TabletSCD5e0ef968-dff3-4446-8412-8085677332f03
1014678cetirizine HCl 10 MG Oral TabletSY5e0ef968-dff3-4446-8412-8085677332f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-294-14680160294141 BOTTLE, PLASTIC in 1 CARTON (68016-294-14) > 14 TABLET, COATED in 1 BOTTLE, PLASTIC2019-11-010000-00-00NoNoCurrent
68016-294-30680160294301 BOTTLE, PLASTIC in 1 CARTON (68016-294-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2019-11-012026-07-31NoNoCurrent
68016-294-60680160294601 BOTTLE, PLASTIC in 1 CARTON (68016-294-60) / 60 TABLET, COATED in 1 BOTTLE, PLASTIC2019-11-012026-07-31NoNoCurrent
68016-294-90680160294901 BOTTLE, PLASTIC in 1 CARTON (68016-294-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2019-11-012026-07-31NoNoCurrent