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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-644
Application NumberANDA076355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 17, 2025
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-643
Application NumberANDA076355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 17, 2025
FDA Product Classification
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