Daliresp

Product NDC

55154-4625

11-digit product format

551544625

Labeler code

55154

Product ID

55154-4625_c4271d86-cc5f-4ed0-bf0d-fefcd6aa1e77

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

roflumilast

Dosage form

TABLET

Route

ORAL

Labeler

Cardinal Health

Application

NDA022522

Marketing category

NDA

Marketing start

2011-02-28

Marketing end

0000-00-00

Substance

ROFLUMILAST

Active strength

500 ug/1

Pharmacologic classes

Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record