Home NDC 70842-101 Baxdela
Product NDC 70842-101
11-digit product format 708420101
Labeler code 70842
Product ID 70842-101_fcc371f3-3214-4036-8834-33337e7cae0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name delafloxacin meglumine
Dosage form TABLET
Route ORAL
Labeler Melinta Therapeutics, LLC
Application NDA208610
Marketing category NDA
Marketing start 2017-06-19
Substance DELAFLOXACIN MEGLUMINE
Active strength 450 mg/1
Pharmacologic classes Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208610-001 BAXDELA DELAFLOXACIN MEGLUMINE EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208610-001 NCE 2022-06-19 N208610-001 GAIN 2027-06-19
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208610-001 BAXDELA EQ 450MG BASE TABLET / ORAL RLD, RS 2017-06-19 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 9 · 332 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 8648093 2025-10-07 U-2028 Drug product 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 8969569 2025-10-07 U-2028 Drug product 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 9539250 2025-10-07 U-2028 Drug substance, Drug product 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208610-001 8648093 2025-10-07 U-2028 Drug product 2017-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 8969569 2025-10-07 U-2028 Drug product 2017-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 9539250 2025-10-07 U-2028 Drug substance, Drug product 2017-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 8648093 2025-10-07 U-2028 Drug product 2017-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 8969569 2025-10-07 U-2028 Drug product 2017-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 9539250 2025-10-07 U-2028 Drug substance, Drug product 2017-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 8273892 2026-08-06 Drug substance 2017-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 8871938 2029-09-23 Drug substance 2017-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 RE46617 2029-12-28 Drug substance 2017-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208610-001 7728143 2031-06-19 Drug substance 2017-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208610-001 8648093 2025-10-07 U-2028 Drug product 2017-07-18 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 101 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Baxdela
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DELAFLOXACIN MEGLUMINE 450 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N7V53U4U4T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1927667 Internal RxNorm lookup 1927672 Internal RxNorm lookup 1927677 Internal RxNorm lookup 1927682 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 70842-101-01 2025-08-07 These 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 70842-101-02 2025-08-07 These 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 70842-101-05 2025-08-07 These 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 70842-101-01 2025-07-29 These 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 70842-101-02 2025-07-29 These 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 70842-101-05 2025-07-29 These 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70842-101 BAXDELA (DELAFLOXACIN MEGLUMINE) TABLET BAXDELA (DELAFLOXACIN MEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] 20 Current NDC, Legacy NDC, 6 package rows 20250426_fb77637a-88d9-4aea-958f-e270030ce30d.zip
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baxdela DELAFLOXACIN MEGLUMINE Melinta Therapeutics, LLC fb77637a-88d9-4aea-958f-e270030ce30d 2025-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208610 application number: NDA208610 ndc (product): 70842-101
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70842-101-01 70842010101 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE 1 bottle 2017-06-19 0000-00-00 No No Current 70842-101-02 70842010102 2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03) 2 blister pack 2017-06-19 0000-00-00 No No Current 70842-101-03 70842010103 10 in 1 BLISTER PACK Historical 70842-101-05 70842010105 1 BLISTER PACK in 1 CARTON (70842-101-05) / 2 TABLET in 1 BLISTER PACK 1 blister pack 2018-05-09 0000-00-00 Yes No Current