Levalbuterol

Product NDC

0378-9681

11-digit product format

003789681

Labeler code

0378

Product ID

0378-9681_111e97b2-4366-4552-8bf8-c2f944fd317e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

levalbuterol

Dosage form

SOLUTION

Route

RESPIRATORY (INHALATION)

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA077800

Marketing category

ANDA

Marketing start

2013-03-15

Marketing end

2019-08-31

Substance

LEVALBUTEROL HYDROCHLORIDE

Active strength

1 mg/3mL

Pharmacologic classes

Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record