Budesonide
These highlights do not include all the information needed to use BUDESONIDE INHALATION SUSPENSION safely and effectively. See full prescribing information for BUDESONIDE INHALATION SUSPENSION. BUDESONIDE Inhalation Suspension, for inhalation suspension Initial U.S. Approval: 2000
Approved
Approval ID
f12043df-f9a3-4edb-88f8-dd176c1a141c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2021
Manufacturers
FDA
Nephron Pharmaceuticals Corporation
DUNS: 079160190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BUDESONIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0487-9701
Application NumberANDA078202
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUDESONIDE
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (7)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUDESONIDEActive
Quantity: 0.5 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
BUDESONIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0487-9601
Application NumberANDA078202
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUDESONIDE
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (7)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUDESONIDEActive
Quantity: 0.25 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB