Linezolid

Product NDC: 0781-3431
11-digit product format: 007813431
Labeler code: 0781
Product ID: 0781-3431_731258b6-fb75-4612-b7e6-cfec8f312aaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Linezolid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA200904
Marketing category: ANDA
Marketing start: 2016-06-15
Substance: LINEZOLID
Active strength: 200 mg/100mL
Pharmacologic classes: Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0781-3431	0781-3431-95	D	Discontinued by firm		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 · 12 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…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200904-001	LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2015-07-16
A200904-002	LINEZOLID	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2015-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A200904-001	AP
A200904-002	AP

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 3 · 82 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	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200904-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200904-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2015-07-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A200904-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200904-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200904-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200904-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200904-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200904-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200904-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200904-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200904-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200904-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200904-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200904-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200904-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200904-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200904-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200904-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200904-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200904-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200904-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200904-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200904-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200904-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200904-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200904-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200904-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200904-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200904-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200904-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200904-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200904-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200904-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200904-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200904-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200904-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200904-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200904-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200904-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200904-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200904-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200904-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Linezolid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINEZOLID	200 mg/100mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1662278	Internal RxNorm lookup
1662285	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
a287cdf4-47a8-459f-8890-86181af5e836	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
51fd7f50-f4ab-45ea-852e-f4101dca346b	Product name	1	20150622
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-3431-46	Linezolid	100 mL in 1 BAG	INJECTION, SOLUTION	100		18
0781-3431-95	Linezolid	10 in 1 CARTON	INJECTION, SOLUTION	10		18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3431	LINEZOLID INJECTION, SOLUTION [SANDOZ INC]	18	Current NDC, Legacy NDC, 2 package rows	20240830_a287cdf4-47a8-459f-8890-86181af5e836.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	Sandoz Inc	a287cdf4-47a8-459f-8890-86181af5e836	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200904 application number: ANDA200904 ndc (product): 0781-3431

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
1662278	linezolid 200 MG in 100 ML Injection	PSN	a287cdf4-47a8-459f-8890-86181af5e836	18
1662285	linezolid 600 MG in 300 ML Injection	PSN	a287cdf4-47a8-459f-8890-86181af5e836	18
1662278	100 ML linezolid 2 MG/ML Injection	SCD	a287cdf4-47a8-459f-8890-86181af5e836	18
1662285	300 ML linezolid 2 MG/ML Injection	SCD	a287cdf4-47a8-459f-8890-86181af5e836	18
1662278	linezolid 200 MG per 100 ML Injection	SY	a287cdf4-47a8-459f-8890-86181af5e836	18
1662285	linezolid 600 MG per 300 ML Injection	SY	a287cdf4-47a8-459f-8890-86181af5e836	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3431-46	00781343146	100 mL in 1 BAG (0781-3431-46)	100 ml	2016-06-15	0000-00-00	No	No	Current
0781-3431-95	00781343195	10 BAG in 1 CARTON (0781-3431-95) > 100 mL in 1 BAG	10 bag	2016-06-15	0000-00-00	No	No	Current