FDA Product

albuterol sulfate

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

Basic Information

Product Name

albuterol sulfate

FDA Product Code

51407-368

Regulatory Information

NDC Product Code

51407-368

Application Number

ANDA072637

Marketing Category

C73584

Effective Date

October 19, 2023

Territorial Authority

USA

FDA Title

ALBUTEROL TABLETS USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerGolden State Medical Supply

DUNS Number

603184490

Active Ingredients

ALBUTEROL SULFATE

Quantity: 4 mg in 1 1

Code: 021SEF3731

Class Code: ACTIM

Inactive Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

ALBUTEROL

Code: QF8SVZ843E

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