FDA.reportPublic FDA data

Cetirizine hydrochloride

Product NDC
23155-292
11-digit product format
231550292
Labeler code
23155
Product ID
23155-292_7fc0aa5e-9571-6334-e053-2991aa0a23b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc.
Application
ANDA078870
Marketing category
ANDA
Marketing start
2016-09-02
Marketing end
2020-03-31
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
0000-00-00
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN66058b6a-c97a-471d-b838-3857fb57ca5a7
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD66058b6a-c97a-471d-b838-3857fb57ca5a7
1014673cetirizine HCl 1 MG/ML Oral SyrupSY66058b6a-c97a-471d-b838-3857fb57ca5a7
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY66058b6a-c97a-471d-b838-3857fb57ca5a7