Loperamide Hydrochloride

Product NDC
70518-0893
11-digit product format
705180893
Labeler code
70518
Product ID
70518-0893_e297b705-8073-f7c3-e053-2a95a90a8c5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA072741
Marketing category
ANDA
Marketing start
2017-12-14
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
70518-0893-07051808930030 CAPSULE in 1 BLISTER PACK (70518-0893-0) 30 capsule2021-08-120000-00-00NoNoCurrent
70518-0893-17051808930115 CAPSULE in 1 BLISTER PACK (70518-0893-1) 15 capsule2019-08-270000-00-00NoNoCurrent
70518-0893-27051808930260 CAPSULE in 1 BOTTLE, PLASTIC (70518-0893-2) 60 capsule2020-05-130000-00-00NoNoCurrent
70518-0893-37051808930320 CAPSULE in 1 BLISTER PACK (70518-0893-3) 20 capsule2021-08-120000-00-00NoNoCurrent