levocetirizine dihydrochloride

Product NDC
0536-1144
11-digit product format
005361144
Labeler code
0536
Product ID
0536-1144_5a7871a8-acf6-8a96-d5b1-d9446a5518cf
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-04-20
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1144-19EA - Each0536-11443593221e-f1fa-49d0-8756-200169c3e00f12019-05-02
0536-1144-92EA - Each0536-1144b280b33b-7824-4535-8e10-7d2efaaa20dd12018-05-09
0536-1144-93EA - Each0536-114414c13e66-0543-4d46-b9b3-7bf3175b04de12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1144-19005361144192 BLISTER PACK in 1 CARTON (0536-1144-19) > 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-07-060000-00-00NoNoCurrent
0536-1144-92005361144921 BOTTLE in 1 CARTON (0536-1144-92) > 35 TABLET, COATED in 1 BOTTLE1 bottle2018-04-200000-00-00NoNoCurrent
0536-1144-93005361144931 BOTTLE in 1 CARTON (0536-1144-93) > 55 TABLET, COATED in 1 BOTTLE1 bottle2018-04-200000-00-00NoNoCurrent