Cetirizine Hydrochloride

Product NDC
50090-4288
11-digit product format
500904288
Labeler code
50090
Product ID
50090-4288_7d2a36e2-fbb0-469c-9eb1-3a02b9ba16ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078398
Marketing category
ANDA
Marketing start
2008-07-24
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4288-02023-02-07C16284748780-1f386c64a-03ff-0266-e053-dadaa90a7c1a7f80130b-1759-46a1-b8ff-3f579a084e4a
50090-4288-02023-01-30C16284748780-1f386c64a-03ff-0266-e053-dadaa90a7c1a7f80130b-1759-46a1-b8ff-3f579a084e4a

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4288-0500904288001 BOTTLE in 1 CARTON (50090-4288-0) > 120 mL in 1 BOTTLE1 bottle2019-04-300000-00-00NoNoCurrent