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 9 of 24 · 476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWalgreen Company8753a131-f8b1-48e1-993b-73c1ee635fef2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATECVS Pharmacy186732a3-13b9-4ea2-ba54-424f63298a2e2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
basic care omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLC4587f491-04ef-4c31-b7b6-bfafd31776fb2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEH E Bddc8d73f-f4a1-42a7-89ee-420346820f612025-11-03WarningsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Me NaPhos MB Hyo 1URINARY ANTISEPTIC ANTISPASMODICMethod Pharmaceuticals2ae628e7-3b33-6a9a-e054-00144ff8d46c2025-10-21Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: XF417D3PSL
unii: 8MDF5V39QO
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
unii: 8MDF5V39QO
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 8MDF5V39QO
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 8MDF5V39QO
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 8MDF5V39QO
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: XF417D3PSL
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.cb657607-b038-47ee-b4e7-a5f419a14c332025-10-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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