FDA.reportPublic FDA data

Xenleta

Product NDC
72000-110
11-digit product format
720000110
Labeler code
72000
Product ID
72000-110_772b4b36-4627-4087-8a16-c1ed771939c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lefamulin acetate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Nabriva Therapeutics US, Inc.
Application
NDA211672
Marketing category
NDA
Marketing start
2019-09-09
Marketing end
0000-00-00
Substance
LEFAMULIN ACETATE
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72000-110IInactivated by FDA2026-07-31
excluded packagepackage72000-11072000-110-10IInactivated by FDA2026-07-31
excluded packagepackage72000-11072000-110-30IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211672-001XENLETALEFAMULIN ACETATEEQ 600MG BASETABLET / ORALRLD, RS2019-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211672-00181536892028-03-19Drug substance, Drug product2019-09-17
N211672-00191207272031-05-23Drug substance, Drug product2019-09-17
N211672-00180716432033-03-25Drug substance, Drug product2019-09-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N211672-001NCE2024-08-19
N211672-001GAIN2029-08-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N211672-001XENLETAEQ 600MG BASETABLET / ORALRLD, RS2019-08-19a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N211672-00181536892028-03-19Drug substance, Drug product2019-09-17a50c72e98297…
2026-08-01 22:54:322026-06N211672-00191207272031-05-23Drug substance, Drug product2019-09-17a50c72e98297…
2026-08-01 22:54:322026-06N211672-00180716432033-03-25Drug substance, Drug product2019-09-17a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N211672-001NCE2024-08-19a50c72e98297…
2026-08-01 22:54:322026-06N211672-001GAIN2029-08-19a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 211672
application number: NDA211672

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b43cec0b-21e9-4d34-a794-f1d7b3d1f30dProduct name120200204
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72000-110-10Xenleta10 in 1 BLISTER PACKTABLET, COATED109
72000-110-30Xenleta30 in 1 BOTTLETABLET, COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72000-110-10EA - Each72000-11049d16678-3df4-4094-949b-1176698c173612021-12-08
72000-110-30EA - Each72000-110a78a6ab1-52fd-431d-b3c4-7a67d5b7db5b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72000-110XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.]9Legacy NDC, 2 package rows20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2198948lefamulin 150 MG in 15 ML InjectionPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
2198961lefamulin 600 MG Oral TabletPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
2198953Xenleta 150 MG in 15 ML InjectionPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
2198966Xenleta 600 MG Oral TabletPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
219895315 ML lefamulin 10 MG/ML Injection [Xenleta]SBD101db63d-2fe2-48df-8506-1382d6dcd4a39
2198966lefamulin 600 MG Oral Tablet [Xenleta]SBD101db63d-2fe2-48df-8506-1382d6dcd4a39
219894815 ML lefamulin 10 MG/ML InjectionSCD101db63d-2fe2-48df-8506-1382d6dcd4a39
2198961lefamulin 600 MG Oral TabletSCD101db63d-2fe2-48df-8506-1382d6dcd4a39
219895315 ML Xenleta 10 MG/ML InjectionSY101db63d-2fe2-48df-8506-1382d6dcd4a39
2198948lefamulin 150 MG per 15 ML InjectionSY101db63d-2fe2-48df-8506-1382d6dcd4a39
2198953Xenleta 150 MG per 15 ML InjectionSY101db63d-2fe2-48df-8506-1382d6dcd4a39
2198966Xenleta 600 MG Oral TabletSY101db63d-2fe2-48df-8506-1382d6dcd4a39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72000-110-107200001101010 TABLET, COATED in 1 BLISTER PACK (72000-110-10) 2019-09-090000-00-00NoNoCurrent
72000-110-307200001103030 TABLET, COATED in 1 BOTTLE (72000-110-30) 2019-09-090000-00-00NoNoCurrent