Loperamide Hydrochloride

Product NDC
0615-8087
11-digit product format
006158087
Labeler code
0615
Product ID
0615-8087_091e9385-faad-4436-a762-7f00e025c61f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA072741
Marketing category
ANDA
Marketing start
1991-09-18
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8087-390061580873930 CAPSULE in 1 BLISTER PACK (0615-8087-39) 30 capsule1991-09-180000-00-00NoNoCurrent