Cetirizine Hydrochloride

Product NDC
63187-436
11-digit product format
631870436
Labeler code
63187
Product ID
63187-436_94b97b2e-11b6-42ad-96f5-3d4030347dd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078488
Marketing category
ANDA
Marketing start
2013-12-03
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-436CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]3Legacy NDC20200219_26d8bc1c-59bc-425a-bdb0-5f97e6dcdbe0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-436-0463187043604120 mL in 1 BOTTLE, GLASS (63187-436-04) 120 ml2019-01-010000-00-00NoNoCurrent