FDA.reportPublic FDA data

Cetirizine

Product NDC
21695-878
11-digit product format
216950878
Labeler code
21695
Product ID
21695-878_5e652955-bce3-4b0a-a754-739712725aaf
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
LIQUID
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078398
Marketing category
ANDA
Marketing start
2008-06-17
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-878-042019-09-24C16284748780-1934fe258-4adc-48b1-e053-8cdaa90a720aCetirizine HCl Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-878-04Cetirizine120 mL in 1 BOTTLELIQUID1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-878-04ML - Milliliter21695-8787ef1bc9c-99c4-4fc4-b785-9fb058dbd8ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-878CETIRIZINE LIQUID [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110223_5e652955-bce3-4b0a-a754-739712725aaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN5e652955-bce3-4b0a-a754-739712725aaf1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD5e652955-bce3-4b0a-a754-739712725aaf1
1014673cetirizine HCl 1 MG/ML Oral SyrupSY5e652955-bce3-4b0a-a754-739712725aaf1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY5e652955-bce3-4b0a-a754-739712725aaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-878-0421695087804120 mL in 1 BOTTLE120 mlHistorical