Amikacin Sulfate
Amikacin Sulfate Injection, USP
Approved
Approval ID
c0f57839-1c9b-49e5-8c7a-708e2d16495d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amikacin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-815
Application NumberANDA205604
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amikacin Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
AMIKACIN SULFATEActive
Quantity: 250 mg in 1 mL
Code: N6M33094FD
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT