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Albuterol Sulfate

Albuterol Sulfate Inhalation Solution 0.63 mg* / 3 mL and 1.25 mg* / 3 mL

Approved
Approval ID

774b1ef9-015e-4e8e-9c52-d305de1ef85e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Albuterol Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5709
Application NumberANDA076355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 12, 2010
FDA Product Classification

INGREDIENTS (4)

ALBUTEROL SULFATEActive
Quantity: 1.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT

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Albuterol Sulfate - FDA Drug Approval Details