Xenleta

Product NDC: 72000-120
11-digit product format: 720000120
Labeler code: 72000
Product ID: 72000-120_772b4b36-4627-4087-8a16-c1ed771939c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lefamulin acetate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Nabriva Therapeutics US, Inc.
Application: NDA211673
Marketing category: NDA
Marketing start: 2019-09-09
Marketing end: 0000-00-00
Substance: LEFAMULIN ACETATE
Active strength: 150 mg/15mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72000-120		I	Inactivated by FDA		2026-08-17
excluded package	package	72000-120	72000-120-06	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N211673-001	XENLETA	LEFAMULIN ACETATE	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		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
N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17
N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17
N211673-001	12121582	2036-06-14	Drug product	2025-05-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211673-001	NCE	2024-08-19
N211673-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2019-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2019-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	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	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	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	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`4b0b4de00fa7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211673-001	NCE	2024-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211673-001	GAIN	2029-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211673-001	NCE	2024-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211673-001	GAIN	2029-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	NCE	2024-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	GAIN	2029-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211673-001	NCE	2024-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211673-001	GAIN	2029-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	NCE	2024-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	GAIN	2029-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	NCE	2024-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	GAIN	2029-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	NCE	2024-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	GAIN	2029-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	NCE	2024-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	GAIN	2029-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	NCE	2024-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	GAIN	2029-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	NCE	2024-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	GAIN	2029-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211673-001	NCE	2024-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211673-001	GAIN	2029-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	NCE	2024-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	GAIN	2029-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	NCE	2024-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	GAIN	2029-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	NCE	2024-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	GAIN	2029-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211673-001	NCE	2024-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211673-001	GAIN	2029-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	NCE	2024-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	GAIN	2029-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211673-001	NCE	2024-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211673-001	GAIN	2029-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211673-001	NCE	2024-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211673-001	GAIN	2029-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211673-001	NCE	2024-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211673-001	GAIN	2029-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211673-001	NCE	2024-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211673-001	GAIN	2029-08-19	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b43cec0b-21e9-4d34-a794-f1d7b3d1f30d	Product name	1	20200204
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72000-120-01	Xenleta	15 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	15		9
72000-120-06	Xenleta	6 in 1 CARTON	INJECTION, SOLUTION	6		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72000-120-01	ML - Milliliter	72000-120	a4f88f10-1b1d-4b52-a742-d866fefc8e25	1	2019-10-07
72000-120-06	ML - Milliliter	72000-120	7eaffad4-3770-4117-84d7-a09d7cffe26b	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72000-120	XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.]	9	Legacy NDC, 2 package rows	20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.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
Xenleta	LEFAMULIN ACETATE	Meitheal Pharmaceuticals Inc.	eb972ea8-7502-422e-84bb-66cb8e93ca06	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211673 application number: NDA211673

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2198948	lefamulin 150 MG in 15 ML Injection	PSN	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198961	lefamulin 600 MG Oral Tablet	PSN	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198953	Xenleta 150 MG in 15 ML Injection	PSN	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198966	Xenleta 600 MG Oral Tablet	PSN	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198953	15 ML lefamulin 10 MG/ML Injection [Xenleta]	SBD	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198966	lefamulin 600 MG Oral Tablet [Xenleta]	SBD	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198948	15 ML lefamulin 10 MG/ML Injection	SCD	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198961	lefamulin 600 MG Oral Tablet	SCD	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198953	15 ML Xenleta 10 MG/ML Injection	SY	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198948	lefamulin 150 MG per 15 ML Injection	SY	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198953	Xenleta 150 MG per 15 ML Injection	SY	101db63d-2fe2-48df-8506-1382d6dcd4a3	9
2198966	Xenleta 600 MG Oral Tablet	SY	101db63d-2fe2-48df-8506-1382d6dcd4a3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72000-120-01	72000012001	15 mL in 1 VIAL, SINGLE-USE	15 ml					Historical
72000-120-06	72000012006	6 VIAL, SINGLE-USE in 1 CARTON (72000-120-06) > 15 mL in 1 VIAL, SINGLE-USE (72000-120-01)		2019-09-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xenleta	Nabriva Therapeutics US, Inc. \| Nabriva Therapeutics Ireland DAC \| Hovione Limited \| Charles River Endotoxin Microbial Detection Europe \| HOVIONE FARMACIENCIA, S.A. \| Patheon Italia S.p.A \| Almac Pharma Services Limited \| Sharp Packaging Services, LLC	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL	9