Albuterol Sulfate
Albuterol Inhalation Solution, USP 0.021% * (0.63 mg* / 3 mL) and 0.042%* (1.25 mg* / 3 mL)
Approved
Approval ID
32474c0e-af35-69d1-e063-6394a90a53c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Rising Pharma Holdings, Inc
DUNS: 116880195
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albuterol Sulfate
PRODUCT DETAILS
NDC Product Code64980-644
Application NumberANDA076355
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 17, 2025
Generic NameAlbuterol Sulfate
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 1.25 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
Albuterol Sulfate
PRODUCT DETAILS
NDC Product Code64980-643
Application NumberANDA076355
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 17, 2025
Generic NameAlbuterol Sulfate
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 0.63 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 3/17/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/17/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 3/17/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 3/17/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 3/17/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 3/17/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 3/17/2025
ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
LOINC: 34091-9Updated: 3/17/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 3/17/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 3/17/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 3/17/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 3/17/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 3/17/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/17/2025
SPL PATIENT PACKAGE INSERT SECTION
LOINC: 42230-3Updated: 3/17/2025