LEVOCETIRIZINE DIHYDROCHLORIDE

Product NDC
60505-0403
11-digit product format
605050403
Labeler code
60505
Product ID
60505-0403_e62cdcfb-febd-1699-f8a6-60f9e3045216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA202915
Marketing category
ANDA
Marketing start
2017-10-26
Marketing end
2021-05-31
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
1 mg/mL
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
60505-0403-3ML - Milliliter60505-0403897205df-f8eb-416a-bc74-ddca3e2dc2e512017-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0403-3605050403031 BOTTLE, PLASTIC in 1 CARTON (60505-0403-3) > 148 mL in 1 BOTTLE, PLASTIC2017-10-262021-05-31NoNoCurrent