Cetirizine Hydrochloride

Product NDC
50090-3885
11-digit product format
500903885
Labeler code
50090
Product ID
50090-3885_08ef09b8-fa01-465a-b7e7-6925c2072f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078870
Marketing category
ANDA
Marketing start
2018-07-13
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
2021-12-31
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
50090-3885-02023-01-30C16284748780-1f386c64a-2f0b-0266-e053-dadaa90a7c1aCETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3885-0Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3885CETIRIZINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200121_95d73b05-1b3f-404e-be2e-5efc333748b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN95d73b05-1b3f-404e-be2e-5efc333748b73
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD95d73b05-1b3f-404e-be2e-5efc333748b73
1014673cetirizine HCl 1 MG/ML Oral SyrupSY95d73b05-1b3f-404e-be2e-5efc333748b73
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY95d73b05-1b3f-404e-be2e-5efc333748b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3885-050090388500120 mL in 1 BOTTLE (50090-3885-0) 120 ml2018-11-290000-00-00NoNoCurrent