FDA Product

Albuterol Sulfate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Albuterol Sulfate

FDA Product Code

70518-3442

Regulatory Information

NDC Product Code

70518-3442

Application Number

ANDA077839

Marketing Category

C73584

Effective Date

January 11, 2024

Territorial Authority

USA

FDA Title

Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

ALBUTEROL SULFATE

Quantity: 2.5 mg in 3 mL

Code: 021SEF3731

Class Code: ACTIM

Active Moieties

ALBUTEROL

Code: QF8SVZ843E

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