Ipratropium Bromide and Albuterol Sulfate

Product NDC

65302-053

11-digit product format

653020053

Labeler code

65302

Product ID

65302-053_9d49f1ff-409c-7eb8-e053-2a95a90a29b4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ipratropium Bromide and Albuterol Sulfate

Dosage form

SOLUTION

Route

RESPIRATORY (INHALATION)

Labeler

The Ritedose Corporation

Application

ANDA202496

Marketing category

ANDA

Marketing start

2017-10-17

Marketing end

0000-00-00

Substance

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Active strength

3 mg/3mL; mg/3mL

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record