FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
71335-0300
11-digit product format
713350300
Labeler code
71335
Product ID
71335-0300_80b8a53e-8bc2-4bd7-b002-a7736af37618
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077829
Marketing category
ANDA
Marketing start
2009-10-01
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
Cetirizine Hydrochloride
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
71335-0300-1Cetirizine Hydrochloride30 in 1 BOTTLETABLET309
71335-0300-2Cetirizine Hydrochloride14 in 1 BOTTLETABLET149
71335-0300-3Cetirizine Hydrochloride7 in 1 BOTTLETABLET79
71335-0300-4Cetirizine Hydrochloride10 in 1 BOTTLETABLET109
71335-0300-5Cetirizine Hydrochloride15 in 1 BOTTLETABLET159
71335-0300-6Cetirizine Hydrochloride90 in 1 BOTTLETABLET909
71335-0300-7Cetirizine Hydrochloride20 in 1 BOTTLETABLET209
71335-0300-8Cetirizine Hydrochloride60 in 1 BOTTLETABLET609
71335-0300-9Cetirizine Hydrochloride100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0300-1EA - Each71335-0300e20488a2-34f2-42a1-9464-785c88d7188712018-04-19
71335-0300-2EA - Each71335-03001e1d2893-c766-4168-9b20-a69ce74ba67f12018-04-19
71335-0300-6EA - Each71335-030020ca9a0b-511e-439b-a5da-2460e49d5af212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0300CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20240726_4b192084-dfdc-47bc-a968-6f49e137b248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine HCl 10 MG Oral TabletSY4b192084-dfdc-47bc-a968-6f49e137b2489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0300-17133503000130 TABLET in 1 BOTTLE (71335-0300-1) 30 tablet2018-02-160000-00-00NoNoCurrent
71335-0300-27133503000214 TABLET in 1 BOTTLE (71335-0300-2) 14 tablet2018-02-200000-00-00NoNoCurrent
71335-0300-3713350300037 TABLET in 1 BOTTLE (71335-0300-3) 7 tablet2022-02-090000-00-00NoNoCurrent
71335-0300-47133503000410 TABLET in 1 BOTTLE (71335-0300-4) 10 tablet2019-03-190000-00-00NoNoCurrent
71335-0300-57133503000515 TABLET in 1 BOTTLE (71335-0300-5) 15 tablet2022-02-090000-00-00NoNoCurrent
71335-0300-67133503000690 TABLET in 1 BOTTLE (71335-0300-6) 90 tablet2018-02-160000-00-00NoNoCurrent
71335-0300-77133503000720 TABLET in 1 BOTTLE (71335-0300-7) 20 tablet2019-03-070000-00-00NoNoCurrent
71335-0300-87133503000860 TABLET in 1 BOTTLE (71335-0300-8) 60 tablet2021-10-130000-00-00NoNoCurrent
71335-0300-971335030009100 TABLET in 1 BOTTLE (71335-0300-9) 100 tablet2019-05-030000-00-00NoNoCurrent