leader allergy relief d

Product NDC
70000-0392
11-digit product format
700000392
Labeler code
70000
Product ID
70000-0392_6214dba2-5a59-405b-9b51-4243b45f2264
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA077170
Marketing category
ANDA
Marketing start
2018-12-11
Marketing end
2022-05-01
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; mg/1
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
70000-0392-1EA - Each70000-0392b32a9ad7-6bc2-4a76-ac80-1d9b51972be812019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0392-17000003920124 BLISTER PACK in 1 CARTON (70000-0392-1) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2018-12-112022-05-01NoNoCurrent