Amikacin Sulfate Injection, 500 mg/2ml
Amikacin Sulfate Injection, 500 mg / 2ml
Approved
Approval ID
b834ed2b-d0c5-6db3-e053-2995a90aa963
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2021
Manufacturers
FDA
Safrel Pharmaceuticals, LLC.
DUNS: 080566287
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amikacin Sulfate Injection, 500 mg/2ml
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71309-996
Product Classification
G
Generic Name
Amikacin Sulfate Injection, 500 mg/2ml
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 3, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
AMIKACIN SULFATEActive
Quantity: 500 mg in 1 1
Code: N6M33094FD
Classification: ACTIM
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT