DOLEX

Product NDC
55758-004
11-digit product format
557580004
Labeler code
55758
Product ID
55758-004_20cd6922-e370-4cce-affb-a049b9f8d500
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Pharmadel LLC
Application
ANDA079129
Marketing category
ANDA
Marketing start
2013-03-25
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record