Loperamide Hydrochloride

Product NDC
70518-0313
11-digit product format
705180313
Labeler code
70518
Product ID
70518-0313_eaee4911-0b92-6568-e053-2995a90abb27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA072741
Marketing category
ANDA
Marketing start
2017-03-13
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0313-07051803130030 CAPSULE in 1 BLISTER PACK (70518-0313-0) 30 capsule2017-03-130000-00-00NoNoCurrent
70518-0313-17051803130115 CAPSULE in 1 BLISTER PACK (70518-0313-1) 15 capsule2017-07-170000-00-00NoNoCurrent
70518-0313-37051803130310 CAPSULE in 1 BLISTER PACK (70518-0313-3) 10 capsule2019-12-060000-00-00NoNoCurrent