FDA.reportPublic FDA data

Allergy Relief

Product NDC
63868-665
11-digit product format
638680665
Labeler code
63868
Product ID
63868-665_24358839-3c09-2895-e063-6294a90ad893
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC.
Application
ANDA209274
Marketing category
ANDA
Marketing start
2018-09-01
Marketing end
2027-01-31
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
63868-665-14Allergy Relief14 in 1 BOTTLE, PLASTICTABLET, COATED143
63868-665-14Allergy Relief1 in 1 CARTONTABLET, COATED13
63868-665-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED303
63868-665-30Allergy Relief1 in 1 CARTONTABLET, COATED13
63868-665-90Allergy Relief1 in 1 CARTONTABLET, COATED13
63868-665-90Allergy Relief90 in 1 BOTTLE, PLASTICTABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-665-14EA - Each63868-665dc3746b2-b24c-4eb2-beb9-a01bee16cd7212022-08-04
63868-665-30EA - Each63868-665881f445d-bce5-491e-ae37-73a7532be75312022-09-12
63868-665-90EA - Each63868-66501c1f104-cde3-481c-b2b8-940f4b3422f212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-665ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]3Current NDC, Legacy NDC, 6 package rows20241013_4f2d0a71-fda5-435a-a220-3292cd74a42a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4f2d0a71-fda5-435a-a220-3292cd74a42a3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4f2d0a71-fda5-435a-a220-3292cd74a42a3
1014678cetirizine HCl 10 MG Oral TabletSY4f2d0a71-fda5-435a-a220-3292cd74a42a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-665-14638680665141 BOTTLE, PLASTIC in 1 CARTON (63868-665-14) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC2018-09-012027-01-31NoNoCurrent
63868-665-30638680665301 BOTTLE, PLASTIC in 1 CARTON (63868-665-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2018-09-012026-11-30NoNoCurrent
63868-665-90638680665901 BOTTLE, PLASTIC in 1 CARTON (63868-665-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2018-09-012026-10-31NoNoCurrent