Healthy Accents Ibuprofen

Product NDC
55316-461
11-digit product format
553160461
Labeler code
55316
Product ID
55316-461_52b04a12-fccd-41e4-83dc-e6ee460146e0
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
DZA Brands LLC
Application
ANDA076359
Marketing category
ANDA
Marketing start
2011-06-30
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record