FDA.reportPublic FDA data

Baxdela

Product NDC
70842-102
11-digit product format
708420102
Labeler code
70842
Product ID
70842-102_fcc371f3-3214-4036-8834-33337e7cae0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
delafloxacin meglumine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Melinta Therapeutics, LLC
Application
NDA208611
Marketing category
NDA
Marketing start
2017-06-19
Substance
DELAFLOXACIN MEGLUMINE
Active strength
300 mg/10.5mL
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baxdela
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DELAFLOXACIN MEGLUMINE300 mg/10.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7V53U4U4T
Rxcui1927667, 1927672, 1927677, 1927682

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
8daac4cd-509c-4b44-986a-01a0cd1b79abProduct name220200409
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70842-102-032025-08-07C16284748780-13b156c62-33b0-fb37-e063-e6dba90a4e07These 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
70842-102-032025-07-29C16284748780-13b156c62-33b0-fb37-e063-e6dba90a4e07These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70842-102-01Baxdela10.5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10.521
70842-102-03Baxdela10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70842-102-01EA - Each70842-1024c6adc42-a7ff-4774-ba33-4c952b6bfe3112022-06-06
70842-102-03EA - Each70842-102f6f1fed3-cc93-4382-97c6-565d39abe6b112017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70842-102BAXDELA (DELAFLOXACIN MEGLUMINE) TABLET BAXDELA (DELAFLOXACIN MEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]20Current NDC, Legacy NDC, 2 package rows20250426_fb77637a-88d9-4aea-958f-e270030ce30d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1927672Baxdela 300 MG InjectionPSNfb77637a-88d9-4aea-958f-e270030ce30d21
1927682Baxdela 450 MG Oral TabletPSNfb77637a-88d9-4aea-958f-e270030ce30d21
1927667delafloxacin 300 MG InjectionPSNfb77637a-88d9-4aea-958f-e270030ce30d21
1927677delafloxacin 450 MG Oral TabletPSNfb77637a-88d9-4aea-958f-e270030ce30d21
1927672delafloxacin 300 MG Injection [Baxdela]SBDfb77637a-88d9-4aea-958f-e270030ce30d21
1927682delafloxacin 450 MG Oral Tablet [Baxdela]SBDfb77637a-88d9-4aea-958f-e270030ce30d21
1927667delafloxacin 300 MG InjectionSCDfb77637a-88d9-4aea-958f-e270030ce30d21
1927677delafloxacin 450 MG Oral TabletSCDfb77637a-88d9-4aea-958f-e270030ce30d21
1927672Baxdela 300 MG (as delafloxacin meglumine 433 MG) InjectionSYfb77637a-88d9-4aea-958f-e270030ce30d21
1927672Baxdela 300 MG InjectionSYfb77637a-88d9-4aea-958f-e270030ce30d21
1927682Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral TabletSYfb77637a-88d9-4aea-958f-e270030ce30d21
1927682Baxdela 450 MG Oral TabletSYfb77637a-88d9-4aea-958f-e270030ce30d21
1927667delafloxacin 300 MG (as delafloxacin meglumine 433 MG) InjectionSYfb77637a-88d9-4aea-958f-e270030ce30d21
1927677delafloxacin 450 MG (as delafloxacin meglumine 649 MG) Oral TabletSYfb77637a-88d9-4aea-958f-e270030ce30d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70842-102-017084201020110.5 mL in 1 VIAL, GLASS10.5 mlHistorical
70842-102-037084201020310 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01) 2017-06-190000-00-00NoNoCurrent