Xenleta

Product NDC: 71288-037
11-digit product format: 712880037
Labeler code: 71288
Product ID: 71288-037_b9951406-492b-4420-89cc-24fd655824b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lefamulin acetate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Meitheal Pharmaceuticals Inc.
Application: NDA211672
Marketing category: NDA
Marketing start: 2019-09-09
Substance: LEFAMULIN ACETATE
Active strength: 600 mg/1
Pharmacologic classes: Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N211672-001	XENLETA	LEFAMULIN ACETATE	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2019-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17
N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17
N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211672-001	NCE	2024-08-19
N211672-001	GAIN	2029-08-19

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 · 42 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	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL	RLD, RS	2019-08-19	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211672-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`301d65b070ca…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 84 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	N211672-001	NCE	2024-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211672-001	GAIN	2029-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211672-001	NCE	2024-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211672-001	GAIN	2029-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211672-001	NCE	2024-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211672-001	GAIN	2029-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211672-001	NCE	2024-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211672-001	GAIN	2029-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211672-001	NCE	2024-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211672-001	GAIN	2029-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211672-001	NCE	2024-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211672-001	GAIN	2029-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211672-001	NCE	2024-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211672-001	GAIN	2029-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211672-001	NCE	2024-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211672-001	GAIN	2029-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211672-001	NCE	2024-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211672-001	GAIN	2029-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211672-001	NCE	2024-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211672-001	GAIN	2029-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211672-001	NCE	2024-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211672-001	GAIN	2029-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211672-001	NCE	2024-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211672-001	GAIN	2029-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211672-001	NCE	2024-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211672-001	GAIN	2029-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211672-001	NCE	2024-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211672-001	GAIN	2029-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211672-001	NCE	2024-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211672-001	GAIN	2029-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211672-001	NCE	2024-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211672-001	GAIN	2029-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211672-001	NCE	2024-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211672-001	GAIN	2029-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211672-001	NCE	2024-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211672-001	GAIN	2029-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211672-001	NCE	2024-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211672-001	GAIN	2029-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211672-001	NCE	2024-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211672-001	GAIN	2029-08-19	`74a2ff9319b5…`

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: Xenleta
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEFAMULIN ACETATE	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HDN0B924X4	Internal UNII lookup
XF417D3PSL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2198948	Internal RxNorm lookup
2198953	Internal RxNorm lookup
2198961	Internal RxNorm lookup
2198966	Internal RxNorm lookup
2747671	Internal RxNorm lookup
2747672	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
eb972ea8-7502-422e-84bb-66cb8e93ca06	Available on FDA.report

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
Xenleta	LEFAMULIN ACETATE	Meitheal Pharmaceuticals Inc.	eb972ea8-7502-422e-84bb-66cb8e93ca06	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211672 application number: NDA211672 ndc (product): 71288-037

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDN0B924X4	LEFAMULIN ACETATE	1350636-82-6	LEFAMULIN ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71288-037-10	71288003710	10 TABLET, COATED in 1 BLISTER PACK (71288-037-10)	2019-09-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xenleta	Meitheal Pharmaceuticals Inc. \| Kindos Pharmaceuticals Co., Ltd. \| Almac Pharma Services Limited \| Gland Pharma Limited	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	1