FDA.reportPublic FDA data

NDC 70842-101-03 - Baxdela

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70842-101
Requested NDC
70842-101-03
Package NDCs from labels
70842-101-03, 70842-101-02, 70842-101-01, 70842-101-05
Manufacturer
Melinta Therapeutics, LLC | SGS North America Inc. | ScinoPharm Taiwan, Ltd. | Pharma Packaging Solutions, LLC dba Tjoapack, LLC | Bostal LLC
Effective date
2025-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BaxdelaMelinta Therapeutics, LLC | SGS North America Inc. | ScinoPharm Taiwan, Ltd. | Pharma Packaging Solutions, LLC dba Tjoapack, LLC | Bostal LLC2025-08-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70842-101-012025-08-07These 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
70842-101-022025-08-07These 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
70842-101-052025-08-07These 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
70842-101-012025-07-29These 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
70842-101-022025-07-29These 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
70842-101-052025-07-29These 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
70842-101-01Baxdela1 in 1 CARTONTABLET121
70842-101-01Baxdela20 in 1 BOTTLETABLET2021
70842-101-02Baxdela2 in 1 CARTONTABLET221
70842-101-03Baxdela10 in 1 BLISTER PACKTABLET1021
70842-101-05Baxdela2 in 1 BLISTER PACKTABLET221
70842-101-05Baxdela1 in 1 CARTONTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70842-101BAXDELA (DELAFLOXACIN MEGLUMINE) TABLET BAXDELA (DELAFLOXACIN MEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]20Current NDC, Legacy NDC, 6 package rows20250426_fb77637a-88d9-4aea-958f-e270030ce30d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70842-101-01EA - Each70842-10111b6ac4f-9338-4849-bfc3-f990f1eaa5e912017-10-13
70842-101-02EA - Each70842-10138556588-0f9f-4218-aefe-0ec4eb413f0712018-07-03
70842-101-03EA - Each70842-101d12aa971-34e7-48a7-92ee-4a213c34073e12019-08-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 25 · 487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
unii: 8MDF5V39QO
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC4f97d398-2118-0874-e063-6394a90a4ad12026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
unii: 8MDF5V39QO
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 593YOG76RN
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 593YOG76RN
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.