Ibuprofen

Product NDC

68645-561

11-digit product format

686450561

Labeler code

68645

Product ID

68645-561_28670284-c43f-4028-814e-151001018aeb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ibuprofen

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Legacy Pharmaceutical Packaging, LLC

Application

ANDA091625

Marketing category

ANDA

Marketing start

2015-12-21

Marketing end

2019-09-30

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

0000-00-00

Current FDA listing

Historical FDA.report record