Amikacin Sulfate
Amikacin Sulfate Injection, USP Rx only
Approved
Approval ID
7791d3e1-9287-4f75-b4f0-e5d35cacfd6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 2
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 Code23155-786
Application NumberANDA204040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amikacin Sulfate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (4)
AMIKACIN SULFATEActive
Quantity: 1 g in 4 mL
Code: N6M33094FD
Classification: ACTIM
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
Amikacin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-785
Application NumberANDA204040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amikacin Sulfate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
AMIKACIN SULFATEActive
Quantity: 500 mg in 2 mL
Code: N6M33094FD
Classification: ACTIM
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT