AMINOPHYLLINE
AMINOPHYLLINE INJECTION, USP 250mg (25mg/mL) 10mL VIAL
Approved
Approval ID
75c2fc3e-28ac-c1b1-e053-2991aa0aee9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
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 Code51662-1204
Application NumberANDA087242
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMINOPHYLLINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 8, 2024
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