FDA.reportPublic FDA data

Cetirizine Hydrochloride Tablets, 10 mg

Product NDC
25000-220
11-digit product format
250000220
Labeler code
25000
Product ID
25000-220_cbb30ec0-aba7-4035-8f4a-a3e82b064857
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA078933
Marketing category
ANDA
Marketing start
2022-01-13
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
Cetirizine Hydrochloride Tablets, 10 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014676, 1014678

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
25000-220-03Cetirizine Hydrochloride Tablets, 10 mg30 in 1 BOTTLETABLET3013
25000-220-03Cetirizine Hydrochloride Tablets, 10 mg1 in 1 CARTONTABLET113
25000-220-08Cetirizine Hydrochloride Tablets, 10 mg100 in 1 BOTTLETABLET10013
25000-220-08Cetirizine Hydrochloride Tablets, 10 mg1 in 1 CARTONTABLET113
25000-220-14Cetirizine Hydrochloride Tablets, 10 mg1000 in 1 BOTTLETABLET100013
25000-220-78Cetirizine Hydrochloride Tablets, 10 mg7 in 1 BLISTER PACKTABLET713
25000-220-78Cetirizine Hydrochloride Tablets, 10 mg1 in 1 CARTONTABLET113
25000-220-81Cetirizine Hydrochloride Tablets, 10 mg1 in 1 CARTONTABLET113
25000-220-81Cetirizine Hydrochloride Tablets, 10 mg14 in 1 BLISTER PACKTABLET1413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-220CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG (CETIRIZINE HYDROCHLORIDE) TABLET CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [MARKSANS PHARMA LIMITED]10Current NDC, Legacy NDC, 9 package rows20230823_652b0c65-a3f2-4454-9cf2-51a3389282cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN652b0c65-a3f2-4454-9cf2-51a3389282cc13
1014676cetirizine HCl 5 MG Oral TabletPSN652b0c65-a3f2-4454-9cf2-51a3389282cc13
1014678cetirizine hydrochloride 10 MG Oral TabletSCD652b0c65-a3f2-4454-9cf2-51a3389282cc13
1014676cetirizine hydrochloride 5 MG Oral TabletSCD652b0c65-a3f2-4454-9cf2-51a3389282cc13
1014678cetirizine HCl 10 MG Oral TabletSY652b0c65-a3f2-4454-9cf2-51a3389282cc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-220-03250000220031 BOTTLE in 1 CARTON (25000-220-03) / 30 TABLET in 1 BOTTLE1 bottle2022-01-130000-00-00NoNoCurrent
25000-220-08250000220081 BOTTLE in 1 CARTON (25000-220-08) / 100 TABLET in 1 BOTTLE1 bottle2022-01-130000-00-00NoNoCurrent
25000-220-14250000220141000 TABLET in 1 BOTTLE (25000-220-14) 1000 tablet2022-01-130000-00-00NoNoCurrent
25000-220-78250000220781 BLISTER PACK in 1 CARTON (25000-220-78) / 7 TABLET in 1 BLISTER PACK1 blister pack2023-04-17NoNoCurrent
25000-220-81250000220811 BLISTER PACK in 1 CARTON (25000-220-81) / 14 TABLET in 1 BLISTER PACK1 blister pack2023-07-21NoNoCurrent