Home NDC 70842-102 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 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 N208611-001 BAXDELA DELAFLOXACIN MEGLUMINE EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 N208611-001 12558349 2034-03-14 U-3967 2026-03-19 N208611-001 12036219 2034-06-02 U-3967 2024-07-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208611-001 NCE 2022-06-19 N208611-001 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 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208611-001 BAXDELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-19 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 14 · 535 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 N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 12558349 2034-03-14 U-3967 2026-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208611-001 12036219 2034-06-02 U-3967 2024-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 12558349 2034-03-14 U-3967 2026-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208611-001 12036219 2034-06-02 U-3967 2024-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208611-001 8273892 2026-08-06 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 8252813 2026-10-02 U-2028 Drug product 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 7635773 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 8410077 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 9200088 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 9750822 2029-03-13 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 8871938 2029-09-23 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 RE46617 2029-12-28 Drug substance 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 7728143 2031-06-19 Drug substance 2017-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 12138257 2032-05-01 Drug product 2024-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 9493582 2033-02-27 Drug product 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208611-001 12036219 2034-06-02 U-3967 2024-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208611-001 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 N208611-001 9539250 2025-10-07 U-2028 Drug substance, Drug product 2017-07-18 31067a03dcf5…
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 300 mg/10.5mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70842-102-01 Baxdela 10.5 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 10.5 21 70842-102-03 Baxdela 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70842-102 BAXDELA (DELAFLOXACIN MEGLUMINE) TABLET BAXDELA (DELAFLOXACIN MEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] 20 Current NDC, Legacy NDC, 2 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): 208611 application number: NDA208611 ndc (product): 70842-102
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 70842-102-01 70842010201 10.5 mL in 1 VIAL, GLASS 10.5 ml Historical 70842-102-03 70842010203 10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01) 2017-06-19 0000-00-00 No No Current