Leader Loperamide Hydrochloride

Product NDC
49781-061
11-digit product format
497810061
Labeler code
49781
Product ID
49781-061_1d6c3011-4279-485a-8b72-a21da75e16a8
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health
Application
ANDA091292
Marketing category
ANDA
Marketing start
2014-04-23
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49781-061-04ML - Milliliter49781-06197dc3c7e-8019-4100-855d-5398b91aa86012016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49781-061-0449781006104120 mL in 1 BOTTLE (49781-061-04) 120 ml2014-04-230000-00-00NoNoCurrent