ALBUTEROL SULFATE
Rx only PRESCRIBING INFORMATION
Approved
Approval ID
eafa5b05-d692-48e7-a413-30f847547eb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-858
Application NumberANDA206224
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALBUTEROL SULFATE
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 0.83 mg in 1 mL
Code: 021SEF3731
Classification: ACTIM