Linezolid

Product NDC: 50090-8044
11-digit product format: 500908044
Labeler code: 50090
Product ID: 50090-8044_0598c9f6-d688-4a20-81cb-d1a7b5e09445
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Linezolid
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA205517
Marketing category: ANDA
Marketing start: 2015-12-21
Substance: LINEZOLID
Active strength: 600 mg/1
Pharmacologic classes: Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
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
A205517-001	LINEZOLID	LINEZOLID	600MG	TABLET / ORAL	AB	RS	2015-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205517-001	AB

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	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB	RS	2015-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB	RS	2015-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB	RS	2015-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB	RS	2015-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205517-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205517-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205517-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205517-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205517-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205517-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205517-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205517-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205517-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205517-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205517-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205517-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205517-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205517-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205517-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205517-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205517-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205517-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205517-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205517-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205517-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205517-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205517-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205517-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205517-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205517-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205517-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205517-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205517-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205517-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205517-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205517-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205517-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205517-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205517-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205517-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205517-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205517-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205517-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205517-001	AB	1	`f41ea6bd6efb…`

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: Linezolid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINEZOLID	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ISQ9I6J12J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311347	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
3d630d3d-510d-43a4-8703-8b6234831564	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	A-S Medication Solutions	3d630d3d-510d-43a4-8703-8b6234831564	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205517 application number: ANDA205517 ndc (product): 50090-8044
Linezolid	LINEZOLID	Sportpharm LLC	7368298b-d75c-4950-bbc1-00fc53f472ec	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205517 application number: ANDA205517
Linezolid	LINEZOLID	REMEDYREPACK INC.	3e0d868d-f419-47e8-a3bc-41ececac468b	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205517 application number: ANDA205517
Linezolid	LINEZOLID	Major Pharmaceuticals	bef116a8-427d-4855-86de-0017e01430b0	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205517 application number: ANDA205517
Linezolid	LINEZOLID	Bryant Ranch Prepack	ab1b4ab5-7338-4b01-963b-43eeb4c9cf1c	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205517 application number: ANDA205517
Linezolid	LINEZOLID	Ascend Laboratories, LLC	7402aa01-50de-46c8-a341-d30da5b32b1c	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205517 application number: ANDA205517

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ISQ9I6J12J	LINEZOLID	165800-03-3	LINEZOLID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-8044-0	50090804400	20 TABLET, FILM COATED in 1 BOTTLE (50090-8044-0)	2026-09-01	No	No	Current