Baxdela

Product NDC: 70842-102
Requested package NDC: 70842-102-03
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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N208611-001	NCE	2022-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208611-001	GAIN	2027-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208611-001	NCE	2022-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208611-001	GAIN	2027-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208611-001	NCE	2022-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208611-001	GAIN	2027-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208611-001	NCE	2022-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208611-001	GAIN	2027-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208611-001	NCE	2022-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208611-001	GAIN	2027-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208611-001	NCE	2022-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208611-001	GAIN	2027-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208611-001	NCE	2022-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208611-001	GAIN	2027-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208611-001	NCE	2022-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208611-001	GAIN	2027-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208611-001	NCE	2022-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208611-001	GAIN	2027-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208611-001	NCE	2022-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208611-001	GAIN	2027-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208611-001	NCE	2022-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208611-001	GAIN	2027-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208611-001	NCE	2022-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208611-001	GAIN	2027-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208611-001	NCE	2022-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208611-001	GAIN	2027-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208611-001	NCE	2022-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208611-001	GAIN	2027-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208611-001	NCE	2022-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208611-001	GAIN	2027-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208611-001	NCE	2022-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208611-001	GAIN	2027-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208611-001	NCE	2022-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208611-001	I-815	2022-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208611-001	GAIN	2027-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208611-001	NCE	2022-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208611-001	I-815	2022-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208611-001	GAIN	2027-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208611-001	NCE	2022-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208611-001	I-815	2022-10-24	`4b0b4de00fa7…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fb77637a-88d9-4aea-958f-e270030ce30d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
8daac4cd-509c-4b44-986a-01a0cd1b79ab	Product name	2	20200409
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70842-102-03	2025-08-07	C162847	48780-1	3b156c62-33b0-fb37-e063-e6dba90a4e07	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
70842-102-03	2025-07-29	C162847	48780-1	3b156c62-33b0-fb37-e063-e6dba90a4e07	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#

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70842-102-01	EA - Each	70842-102	4c6adc42-a7ff-4774-ba33-4c952b6bfe31	1	2022-06-06
70842-102-03	EA - Each	70842-102	f6f1fed3-cc93-4382-97c6-565d39abe6b1	1	2017-10-13

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 (package): 70842-102-03 ndc (product): 70842-102 ndc11 (package): 70842010203

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7V53U4U4T	DELAFLOXACIN MEGLUMINE	352458-37-8	DELAFLOXACIN MEGLUMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1927672	Baxdela 300 MG Injection	PSN	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927682	Baxdela 450 MG Oral Tablet	PSN	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927667	delafloxacin 300 MG Injection	PSN	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927677	delafloxacin 450 MG Oral Tablet	PSN	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927672	delafloxacin 300 MG Injection [Baxdela]	SBD	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927682	delafloxacin 450 MG Oral Tablet [Baxdela]	SBD	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927667	delafloxacin 300 MG Injection	SCD	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927677	delafloxacin 450 MG Oral Tablet	SCD	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927672	Baxdela 300 MG (as delafloxacin meglumine 433 MG) Injection	SY	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927672	Baxdela 300 MG Injection	SY	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927682	Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet	SY	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927682	Baxdela 450 MG Oral Tablet	SY	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927667	delafloxacin 300 MG (as delafloxacin meglumine 433 MG) Injection	SY	fb77637a-88d9-4aea-958f-e270030ce30d	21
1927677	delafloxacin 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet	SY	fb77637a-88d9-4aea-958f-e270030ce30d	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baxdela	Melinta Therapeutics, LLC \| SGS North America Inc. \| ScinoPharm Taiwan, Ltd. \| Pharma Packaging Solutions, LLC dba Tjoapack, LLC \| Bostal LLC	2025-08-01	HUMAN PRESCRIPTION DRUG LABEL	21