Aminophylline
Approved
Approval ID
9a663ef3-881f-48bd-2689-3713b24545c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aminophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-5922
Application NumberANDA087242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminophylline
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (3)
ETHYLENEDIAMINEInactive
Code: 60V9STC53F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMINOPHYLLINE DIHYDRATEActive
Quantity: 25 mg in 1 mL
Code: C229N9DX94
Classification: ACTIB
Aminophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-5921
Application NumberANDA087242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminophylline
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (3)
ETHYLENEDIAMINEInactive
Code: 60V9STC53F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMINOPHYLLINE DIHYDRATEActive
Quantity: 25 mg in 1 mL
Code: C229N9DX94
Classification: ACTIB