Tobramycin
TOBRAMYCIN Injection, USP PHARMACY BULK PACKAGE —NOT FOR DIRECT INFUSION Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
02b48684-168c-4cd9-8375-794206eff23e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 27, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tobramycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-241
Application NumberANDA209346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 27, 2023
FDA Product Classification
INGREDIENTS (6)
TOBRAMYCIN SULFATEActive
Quantity: 40 mg in 1 mL
Code: HJT0RXD7JK
Classification: ACTIM
SODIUM METABISULFITEInactive
Quantity: 3.2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT