Linezolid
These highlights do not include all the information needed to use LINEZOLID FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LINEZOLID FOR ORAL SUSPENSION. LINEZOLID for oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
e9ac1ad7-7a23-463d-a467-f0ecc7e523e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Linezolid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-754
Application NumberANDA211813
Product Classification
M
Marketing Category
C73584
G
Generic Name
Linezolid
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (14)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
LINEZOLIDActive
Quantity: 100 mg in 5 mL
Code: ISQ9I6J12J
Classification: ACTIB