Baxdela
These highlights do not include all the information needed to use BAXDELA safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017
Approved
Approval ID
fb77637a-88d9-4aea-958f-e270030ce30d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2021
Manufacturers
FDA
Melinta Therapeutics, LLC
DUNS: 079949853
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
delafloxacin meglumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70842-101
Application NumberNDA208610
Product Classification
M
Marketing Category
C73594
G
Generic Name
delafloxacin meglumine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2021
FDA Product Classification
INGREDIENTS (9)
POVIDONE K30Inactive
Quantity: 34 mg in 1 1
Code: U725QWY32X
Classification: IACT
DELAFLOXACIN MEGLUMINEActive
Quantity: 450 mg in 1 1
Code: N7V53U4U4T
Classification: ACTIM
CROSPOVIDONE (35 .MU.M)Inactive
Quantity: 109 mg in 1 1
Code: 40UAA97IT9
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 140 mg in 1 1
Code: 8MDF5V39QO
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 5.5 mg in 1 1
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 10 mg in 1 1
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Quantity: 417 mg in 1 1
Code: OP1R32D61U
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 5.5 mg in 1 1
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
delafloxacin meglumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70842-102
Application NumberNDA208611
Product Classification
M
Marketing Category
C73594
G
Generic Name
delafloxacin meglumine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 2, 2021
FDA Product Classification
INGREDIENTS (7)
DELAFLOXACIN MEGLUMINEActive
Quantity: 300 mg in 10.5 mL
Code: N7V53U4U4T
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BETADEX SULFOBUTYL ETHER SODIUMInactive
Quantity: 2400 mg in 10.5 mL
Code: 2PP9364507
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MEGLUMINEInactive
Quantity: 59 mg in 10.5 mL
Code: 6HG8UB2MUY
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 3.4 mg in 10.5 mL
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT