Ibuprofen

Product NDC
57910-300
11-digit product format
579100300
Labeler code
57910
Product ID
57910-300_46faf860-1949-4729-a4d7-3248e9012013
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Shasun Pharmaceuticals Limited
Application
ANDA078329
Marketing category
ANDA
Marketing start
2009-02-05
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record