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Xenleta

These highlights do not include all the information needed to use XENLETA safely and effectively. See full prescribing information for XENLETA. XENLETA (lefamulin) injection, for intravenous use XENLETA (lefamulin) tablets, for oral use Initial U.S. Approval: 2019

Approved
Approval ID

101db63d-2fe2-48df-8506-1382d6dcd4a3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2022

Manufacturers
FDA

Nabriva Therapeutics US, Inc.

DUNS: 072863844

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

anhydrous citric acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72000-030
Application NumberNDA211673
Product Classification
M
Marketing Category
C73594
G
Generic Name
anhydrous citric acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2021
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDActive
Quantity: 166 mg in 270 mL
Code: XF417D3PSL
Classification: ACTIB

lefamulin acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72000-110
Application NumberNDA211672
Product Classification
M
Marketing Category
C73594
G
Generic Name
lefamulin acetate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2021
FDA Product Classification

INGREDIENTS (9)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LEFAMULIN ACETATEActive
Quantity: 600 mg in 1 1
Code: HDN0B924X4
Classification: ACTIM
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSEInactive
Code: 029TFK992N
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

lefamulin acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72000-120
Application NumberNDA211673
Product Classification
M
Marketing Category
C73594
G
Generic Name
lefamulin acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2021
FDA Product Classification

INGREDIENTS (3)

LEFAMULIN ACETATEActive
Quantity: 150 mg in 15 mL
Code: HDN0B924X4
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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