FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
33261-924
11-digit product format
332610924
Labeler code
33261
Product ID
33261-924_452bde3e-2197-4249-8e06-97f3c7fcd9de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078488
Marketing category
ANDA
Marketing start
2018-08-17
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-924-012020-01-31C16284748780-19d75b9d0-e61d-f424-e053-dadaa90a57ceCetirizine Hydrochloride Oral Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-924-01Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-924-01ML - Milliliter33261-924f26d1cf2-25d5-4be9-ba42-f2e4969196b012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-924CETIRIZINE HYDROCHLORIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180825_fbea1782-20c3-45ea-bf01-4edf86d12752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNfbea1782-20c3-45ea-bf01-4edf86d127521
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDfbea1782-20c3-45ea-bf01-4edf86d127521
1014673cetirizine HCl 1 MG/ML Oral SyrupSYfbea1782-20c3-45ea-bf01-4edf86d127521
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYfbea1782-20c3-45ea-bf01-4edf86d127521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-924-0133261092401120 mL in 1 BOTTLE120 mlHistorical