Healthy Accents Anti Diarrheal

Product NDC
55316-645
11-digit product format
553160645
Labeler code
55316
Product ID
55316-645_7e7b73bb-37ef-435b-97b3-7bad2ee161d0
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
DZA Brands LLC
Application
ANDA091292
Marketing category
ANDA
Marketing start
2017-02-23
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