FDA.reportPublic FDA data

Cetirizine hydrochloride

Product NDC
70010-163
11-digit product format
700100163
Labeler code
70010
Product ID
70010-163_451b5247-4660-9ebe-e063-6294a90a13c2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA209274
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
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
70010-163-05Cetirizine hydrochloride500 in 1 BOTTLETABLET, COATED5005
70010-163-09Cetirizine hydrochloride90 in 1 BOTTLETABLET, COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-163-05EA - Each70010-1632d6c40a2-afe7-48d3-9100-1e39f13ae6c912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-163CETIRIZINE HYDROCHLORIDE TABLET, COATED [GRANULES PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20230129_d55dfce1-acef-3342-e053-2a95a90a4b83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNd55dfce1-acef-3342-e053-2a95a90a4b835
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd55dfce1-acef-3342-e053-2a95a90a4b835
1014678cetirizine HCl 10 MG Oral TabletSYd55dfce1-acef-3342-e053-2a95a90a4b835
1014678cetirizine HCl 10 MG Oral TabletPSN84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a44
1014678cetirizine hydrochloride 10 MG Oral TabletSCD84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a44
1014678cetirizine HCl 10 MG Oral TabletSY84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a44
1014678cetirizine HCl 10 MG Oral TabletPSNb53d5e8a-a30c-4025-aa72-d2776a112e3e2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb53d5e8a-a30c-4025-aa72-d2776a112e3e2
1014678cetirizine HCl 10 MG Oral TabletSYb53d5e8a-a30c-4025-aa72-d2776a112e3e2
1014678cetirizine HCl 10 MG Oral TabletPSNf4da9adf-840d-4526-86a6-6666183fd1071
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf4da9adf-840d-4526-86a6-6666183fd1071
1014678cetirizine HCl 10 MG Oral TabletSYf4da9adf-840d-4526-86a6-6666183fd1071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-163-0570010016305500 TABLET, COATED in 1 BOTTLE (70010-163-05) 2022-01-130000-00-00NoNoCurrent
70010-163-097001001630990 TABLET, COATED in 1 BOTTLE (70010-163-09) 2022-04-260000-00-00NoNoCurrent