SIVEXTRO

Product NDC: 72000-320
11-digit product format: 720000320
Labeler code: 72000
Product ID: 72000-320_6b3f7c1e-f936-4651-9cfe-43f1634a00c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tedizolid phosphate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Nabriva Therapeutics US, Inc.
Application: NDA205436
Marketing category: NDA
Marketing start: 2014-06-20
Marketing end: 0000-00-00
Substance: TEDIZOLID PHOSPHATE
Active strength: 200 mg/4mL
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
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	72000-320		I	Inactivated by FDA		2026-09-14
excluded package	package	72000-320	72000-320-10	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72000-320-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72000-320-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72000-320-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72000-320-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72000-320-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72000-320-10	`1332a3947898…`	`d4bfe170f9cd…`

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
N205436-001	SIVEXTRO	TEDIZOLID PHOSPHATE	200MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2014-06-20

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03
N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03
N205436-001	10065947	2030-02-03		Drug product	2019-04-09
N205436-001	10442829	2030-02-03		Drug substance	2019-11-13
N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09
N205436-001	9988406	2030-02-03		Drug product	2019-04-09
N205436-001	8426389	2030-12-31	U-282	Drug substance, Drug product	2014-07-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205436-001	NPP	2028-04-04

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	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205436-001	SIVEXTRO	200MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-06-20	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 298 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	N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205436-001	10065947	2030-02-03		Drug product	2019-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205436-001	10442829	2030-02-03		Drug substance	2019-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205436-001	9988406	2030-02-03		Drug product	2019-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205436-001	8426389	2030-12-31	U-282	Drug substance, Drug product	2014-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205436-001	10065947	2030-02-03		Drug product	2019-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205436-001	10442829	2030-02-03		Drug substance	2019-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205436-001	9988406	2030-02-03		Drug product	2019-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205436-001	8426389	2030-12-31	U-282	Drug substance, Drug product	2014-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205436-001	10065947	2030-02-03		Drug product	2019-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205436-001	10442829	2030-02-03		Drug substance	2019-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205436-001	9988406	2030-02-03		Drug product	2019-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205436-001	8426389	2030-12-31	U-282	Drug substance, Drug product	2014-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	10065947	2030-02-03		Drug product	2019-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	10442829	2030-02-03		Drug substance	2019-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	9988406	2030-02-03		Drug product	2019-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	8426389	2030-12-31	U-282	Drug substance, Drug product	2014-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205436-001	10065947	2030-02-03		Drug product	2019-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205436-001	10442829	2030-02-03		Drug substance	2019-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205436-001	9988406	2030-02-03		Drug product	2019-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205436-001	8426389	2030-12-31	U-282	Drug substance, Drug product	2014-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205436-001	8420676	2028-02-23	U-282	Drug substance, Drug product	2014-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205436-001	7816379	2028-06-20	U-2507	Drug substance, Drug product	2014-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205436-001	10065947	2030-02-03		Drug product	2019-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205436-001	10442829	2030-02-03		Drug substance	2019-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205436-001	9624250	2030-02-03	U-2507	Drug substance, Drug product	2019-04-09	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 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	N205436-001	NPP	2028-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205436-001	NPP	2028-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205436-001	NPP	2028-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205436-001	NPP	2028-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205436-001	NPP	2028-04-04	`6a471c1ec25d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205436-001	NCE	2019-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205436-001	GAIN	2024-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205436-001	NCE	2019-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205436-001	GAIN	2024-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205436-001	NCE	2019-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205436-001	GAIN	2024-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205436-001	NCE	2019-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205436-001	GAIN	2024-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205436-001	NCE	2019-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205436-001	GAIN	2024-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205436-001	NCE	2019-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205436-001	GAIN	2024-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205436-001	NCE	2019-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205436-001	GAIN	2024-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205436-001	NCE	2019-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205436-001	GAIN	2024-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205436-001	NCE	2019-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205436-001	GAIN	2024-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205436-001	NCE	2019-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205436-001	NPP	2023-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205436-001	GAIN	2024-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205436-001	NCE	2019-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205436-001	NPP	2023-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205436-001	GAIN	2024-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205436-001	NCE	2019-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205436-001	NPP	2023-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205436-001	GAIN	2024-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205436-001	NCE	2019-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205436-001	GAIN	2024-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205436-001	NCE	2019-06-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205436-001	NPP	2023-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205436-001	GAIN	2024-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205436-001	NCE	2019-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205436-001	NPP	2023-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205436-001	GAIN	2024-06-20	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
20511d74-2137-4dc9-8a06-45c653d4b070	Product name	1	20161117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72000-320-10	2024-11-21	C162847	48780-1	1030e365-65b1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use SIVEXTRO ® safely and effectively. See full prescribing information for SIVEXTRO. SIVEXTRO ® (tedizolid phosphate) for injection, for intravenous use SIVEXTRO ® (tedizolid phosphate) tablet, for oral use Initial U.S. Approval: 2014
72000-320-10	2024-01-30	C162847	48780-1	1030e365-65b1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use SIVEXTRO ® safely and effectively. See full prescribing information for SIVEXTRO. SIVEXTRO ® (tedizolid phosphate) for injection, for intravenous use SIVEXTRO ® (tedizolid phosphate) tablet, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72000-320-10	SIVEXTRO	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		7
72000-320-10	SIVEXTRO	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72000-320-10	EA - Each	72000-320	a27c7fdd-7877-4932-a253-39672036786e	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72000-320	SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NABRIVA THERAPEUTICS US, INC.]	7	Legacy NDC, 2 package rows	20241122_11d5c110-c48c-438f-9c7d-5adf99938534.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
SIVEXTRO	TEDIZOLID PHOSPHATE	Merck Sharp & Dohme LLC	75672079-589f-451a-bdbf-eaebcfcc80a9	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205436 application number: NDA205436

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O7DRJ6R4DW	TEDIZOLID PHOSPHATE	856867-55-5	TEDIZOLID PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1540890	Sivextro 200 MG Injection	PSN	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540868	Sivextro 200 MG Oral Tablet	PSN	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540886	tedizolid phosphate 200 MG Injection	PSN	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540862	tedizolid phosphate 200 MG Oral Tablet	PSN	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540890	tedizolid phosphate 200 MG Injection [Sivextro]	SBD	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540868	tedizolid phosphate 200 MG Oral Tablet [Sivextro]	SBD	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540886	tedizolid phosphate 200 MG Injection	SCD	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540862	tedizolid phosphate 200 MG Oral Tablet	SCD	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540890	Sivextro 200 MG Injection	SY	11d5c110-c48c-438f-9c7d-5adf99938534	7
1540868	Sivextro 200 MG Oral Tablet	SY	11d5c110-c48c-438f-9c7d-5adf99938534	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72000-320-10	72000032010	10 VIAL, GLASS in 1 CARTON (72000-320-10) > 4 mL in 1 VIAL, GLASS	2014-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIVEXTRO	Nabriva Therapeutics US, Inc. \| Merck Sharp & Dohme LLC	2024-11-14	HUMAN PRESCRIPTION DRUG LABEL	7