FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
10135-762
11-digit product format
101350762
Labeler code
10135
Product ID
10135-762_3f7dc523-2934-780a-e063-6294a90a837f
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc
Application
ANDA077498
Marketing category
ANDA
Marketing start
2022-10-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-762-01Cetirizine Hydrochloride100 in 1 BOTTLETABLET1005
10135-762-03Cetirizine Hydrochloride300 in 1 BOTTLETABLET3005
10135-762-05Cetirizine Hydrochloride500 in 1 BOTTLETABLET5005
10135-762-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET305
10135-762-90Cetirizine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-762-01EA - Each10135-7621d6d33c5-9cc3-4559-9658-27092f78956012022-11-07
10135-762-03EA - Each10135-762b3fbd897-67e1-42cb-8ede-416ff0ae4cac12022-11-07
10135-762-05EA - Each10135-762df0f330c-a988-4b03-b537-44cb4326c4f812022-11-07
10135-762-30EA - Each10135-76234fcd845-4aa8-4b5b-9c06-f95b76c7a1b812022-11-07
10135-762-90EA - Each10135-76230940a46-9309-4e33-9a4c-b5163dce108312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-762CETIRIZINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS, INC]4Current NDC, Legacy NDC, 5 package rows20241004_eb917099-fecf-6b55-e053-2995a90aaafa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNeb917099-fecf-6b55-e053-2995a90aaafa5
1014678cetirizine hydrochloride 10 MG Oral TabletSCDeb917099-fecf-6b55-e053-2995a90aaafa5
1014678cetirizine HCl 10 MG Oral TabletSYeb917099-fecf-6b55-e053-2995a90aaafa5
1014678cetirizine HCl 10 MG Oral TabletPSN15eaa0d1-d18d-72b1-e063-6394a90a8a941
1014678cetirizine hydrochloride 10 MG Oral TabletSCD15eaa0d1-d18d-72b1-e063-6394a90a8a941
1014678cetirizine HCl 10 MG Oral TabletSY15eaa0d1-d18d-72b1-e063-6394a90a8a941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-762-0110135076201100 TABLET in 1 BOTTLE (10135-762-01) 100 tablet2022-10-010000-00-00NoNoCurrent
10135-762-0310135076203300 TABLET in 1 BOTTLE (10135-762-03) 300 tablet2022-10-010000-00-00NoNoCurrent
10135-762-0510135076205500 TABLET in 1 BOTTLE (10135-762-05) 500 tablet2022-10-010000-00-00NoNoCurrent
10135-762-301013507623030 TABLET in 1 BOTTLE (10135-762-30) 30 tablet2022-10-010000-00-00NoNoCurrent
10135-762-901013507629090 TABLET in 1 BOTTLE (10135-762-90) 90 tablet2022-10-010000-00-00NoNoCurrent