Cetirizine Hydrochloride

Product NDC
70934-199
11-digit product format
709340199
Labeler code
70934
Product ID
70934-199_f1629845-7641-10b6-e053-2995a90ae98c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077829
Marketing category
ANDA
Marketing start
2018-12-04
Marketing end
2024-09-30
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-199-30EA - Each70934-199ea3c5c16-5f9b-4eda-a956-2d4fa4a9de4b12022-12-07
70934-199-90EA - Each70934-19951a81aed-22d4-4cfd-aeed-478c68f8485012022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-199-307093401993030 TABLET in 1 BOTTLE, PLASTIC (70934-199-30) 30 tablet2019-10-290000-00-00NoNoCurrent
70934-199-907093401999090 TABLET in 1 BOTTLE, PLASTIC (70934-199-90) 90 tablet2018-12-040000-00-00NoNoCurrent
70934-199-9770934019997100 TABLET in 1 BOTTLE, PLASTIC (70934-199-97) 100 tablet2019-10-290000-00-00NoNoCurrent