Cetirizine Hydrochloride

Product NDC
0121-4780
11-digit product format
001214780
Labeler code
0121
Product ID
0121-4780_4a1a8f26-6fea-49cd-85cc-9e7ea7e7eee8
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA090300
Marketing category
ANDA
Marketing start
2009-09-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-4780-052023-06-15C16284748780-1956f9ecf-c4d4-621f-e053-dbdaa90a74adf621a02d-5a92-4aa2-af70-1fd1d993ba75
0121-4780-052019-10-21C16284748780-1956f9ecf-c4d4-621f-e053-dbdaa90a74adf621a02d-5a92-4aa2-af70-1fd1d993ba75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4780-05ML - Milliliter0121-47804b1603cf-c537-4c33-9ae1-e5ad460b01a112012-07-24