Cetirizine Hydrochloride Oral Solution

Product NDC
13668-029
11-digit product format
136680029
Labeler code
13668
Product ID
13668-029_d5f621e8-9a36-8add-e053-2a95a90a5ddf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
Torrent Pharma, Inc.
Application
ANDA078870
Marketing category
ANDA
Marketing start
2018-05-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-029-07ML - Milliliter13668-029fad6bf63-01ec-4b00-be99-833ed90a4e0212021-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-029-0713668002907120 mL in 1 BOTTLE (13668-029-07) 120 ml2018-05-010000-00-00NoNoCurrent
13668-029-1113668002911480 mL in 1 BOTTLE (13668-029-11) 480 ml2021-05-030000-00-00NoNoCurrent