Ibuprofen

Product NDC

55700-633

11-digit product format

557000633

Labeler code

55700

Product ID

55700-633_ce41cb11-f6fd-4989-b260-962b5a93aa2e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ibuprofen

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA202413

Marketing category

ANDA

Marketing start

2018-05-25

Marketing end

0000-00-00

Substance

IBUPROFEN

Active strength

800 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record