Ibuprofen

Product NDC: 57910-402
11-digit product format: 579100402
Labeler code: 57910
Product ID: 57910-402_052870b8-388e-4d0b-b8d5-ddbd106bfe93
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Shasun Pharmaceuticals Limited
Application: ANDA091355
Marketing category: ANDA
Marketing start: 2011-04-04
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