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Product NDC
55316-224
11-digit product format
553160224
Labeler code
55316
Product ID
55316-224_3749411c-423e-4e3b-b017-f8656399f4d3
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DZA Brands LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2008-02-04
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record