UTIBRON NEOHALER

Product NDC

0078-0664

11-digit product format

000780664

Labeler code

0078

Product ID

0078-0664_77de1b47-3665-4fb2-b7a5-31dcbcd63622

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

indacaterol and glycopyrrolate

Dosage form

CAPSULE

Route

RESPIRATORY (INHALATION)

Labeler

Novartis Pharmaceuticals Corporation

Application

NDA207930

Marketing category

NDA

Marketing start

2015-10-29

Marketing end

2019-06-30

Substance

INDACATEROL MALEATE; GLYCOPYRROLATE

Active strength

28 ug/1; ug/1

Pharmacologic classes

Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record