Linezolid

Product NDC: 40032-022
Requested package NDC: 40032-022-05
11-digit product format: 400320022
Labeler code: 40032
Product ID: 40032-022_66a60971-0fe7-42ea-833d-0b95bdae100f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Linezolid
Dosage form: TABLET
Route: ORAL
Labeler: Novel Laboratories, Inc.
Application: ANDA207526
Marketing category: ANDA
Marketing start: 2016-08-22
Marketing end: 0000-00-00
Substance: LINEZOLID
Active strength: 600 mg/1
Pharmacologic classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	40032-022	40032-022-05	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207526-001	LINEZOLID	LINEZOLID	600MG	TABLET / ORAL	AB		2016-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207526-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207526-001	LINEZOLID	600MG	TABLET / ORAL	AB	2016-08-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207526-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207526-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207526-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207526-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207526-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207526-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207526-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207526-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207526-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207526-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207526-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207526-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207526-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207526-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207526-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207526-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207526-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207526-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207526-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207526-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207526-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207526-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207526-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207526-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207526-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207526-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207526-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207526-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207526-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207526-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207526-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207526-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207526-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207526-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207526-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207526-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207526-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207526-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207526-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207526-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
51fd7f50-f4ab-45ea-852e-f4101dca346b	Product name	1	20150622

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40032-022-02	2023-01-30	C162847	48780-1	f386c64a-3db1-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000
40032-022-05	2023-01-30	C162847	48780-1	f386c64a-3db1-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000
40032-022-31	2023-01-30	C162847	48780-1	f386c64a-3db1-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
40032-022-02	Linezolid	20 in 1 BOTTLE	TABLET	20	2
40032-022-05	Linezolid	500 in 1 BOTTLE	TABLET	500	2
40032-022-30	Linezolid	10 in 1 BLISTER PACK	TABLET	10	2
40032-022-31	Linezolid	3 in 1 CARTON	TABLET	3	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-022	LINEZOLID TABLET [NOVEL LABORATORIES, INC.]	2	Legacy NDC, 4 package rows	20191222_13990ee8-8fbe-402d-8aba-cba78964fd32.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
Linezolid	LINEZOLID	Lupin Pharmaceuticals,Inc.	b3c55eb4-50f2-47f0-a424-5a6779518e1d	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207526 application number: ANDA207526

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311347	linezolid 600 MG Oral Tablet	PSN	13990ee8-8fbe-402d-8aba-cba78964fd32	2
311347	linezolid 600 MG Oral Tablet	SCD	13990ee8-8fbe-402d-8aba-cba78964fd32	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
40032-022-05	40032002205	500 TABLET in 1 BOTTLE (40032-022-05)	500 tablet	2016-08-22	0000-00-00	No	No	Current