Amikacin Sulfate
AMIKACIN SULFATE INJECTION, USP
Approved
Approval ID
0b56f6df-a05d-4520-8bf0-d7cefe20f6ad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
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 Code0641-6166
Application NumberANDA063315
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amikacin Sulfate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
AMIKACIN SULFATEActive
Quantity: 250 mg in 1 mL
Code: N6M33094FD
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Amikacin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6167
Application NumberANDA063315
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amikacin Sulfate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (5)
AMIKACIN SULFATEActive
Quantity: 250 mg in 1 mL
Code: N6M33094FD
Classification: ACTIM
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT