Linezolid

Product NDC: 31722-749
11-digit product format: 317220749
Labeler code: 31722
Product ID: 31722-749_2b439d9f-d081-c988-e063-6394a90af390
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Linezolid
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA204239
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: 2026-12-31
Current FDA listing: Yes

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
A204239-001	LINEZOLID	LINEZOLID	600MG	TABLET / ORAL	AB		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
A204239-001	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	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`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	A204239-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204239-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204239-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204239-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204239-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204239-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204239-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204239-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204239-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204239-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204239-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204239-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204239-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204239-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204239-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204239-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204239-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204239-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204239-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204239-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204239-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204239-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204239-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204239-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204239-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204239-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204239-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204239-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204239-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204239-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204239-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204239-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204239-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204239-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204239-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204239-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204239-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204239-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204239-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204239-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
b239458e-9a3e-49ac-9ac7-a4badc53dff6	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-749-01	Linezolid	100 in 1 BOTTLE	TABLET, FILM COATED	100	5
31722-749-20	Linezolid	20 in 1 BOTTLE	TABLET, FILM COATED	20	5
31722-749-30	Linezolid	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
31722-749-31	Linezolid	150 in 1 CARTON	TABLET, FILM COATED	150	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-749-20	EA - Each	31722-749	c8e33aa3-6280-4fcd-aa2e-0c526b5d9264	1	2016-01-13
31722-749-30	EA - Each	31722-749	97f789e2-0661-4230-b307-bf09d611fc63	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-749	LINEZOLID (LINEZOLID) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20250110_b239458e-9a3e-49ac-9ac7-a4badc53dff6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Coupler LLC	3dff6eec-8662-335f-e063-6294a90ab159	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239
Linezolid	LINEZOLID	Bryant Ranch Prepack	8a04bdc9-d6f0-4e35-b683-a472a2e4ff04	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239
Linezolid	LINEZOLID	Camber Pharmaceuticals, Inc.	b239458e-9a3e-49ac-9ac7-a4badc53dff6	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239 ndc (product): 31722-749
Linezolid	LINEZOLID	American Health Packaging	bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239

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	8a04bdc9-d6f0-4e35-b683-a472a2e4ff04	103
311347	linezolid 600 MG Oral Tablet	SCD	8a04bdc9-d6f0-4e35-b683-a472a2e4ff04	103
311347	linezolid 600 MG Oral Tablet	PSN	bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c	6
311347	linezolid 600 MG Oral Tablet	SCD	bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c	6
311347	linezolid 600 MG Oral Tablet	PSN	b239458e-9a3e-49ac-9ac7-a4badc53dff6	5
311347	linezolid 600 MG Oral Tablet	SCD	b239458e-9a3e-49ac-9ac7-a4badc53dff6	5
311347	linezolid 600 MG Oral Tablet	PSN	3dff6eec-8662-335f-e063-6294a90ab159	1
311347	linezolid 600 MG Oral Tablet	SCD	3dff6eec-8662-335f-e063-6294a90ab159	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-749-01	31722074901	100 TABLET, FILM COATED in 1 BOTTLE (31722-749-01)	2015-12-21	0000-00-00	No	No	Current
31722-749-20	31722074920	20 TABLET, FILM COATED in 1 BOTTLE (31722-749-20)	2015-12-21	0000-00-00	No	No	Current
31722-749-30	31722074930	30 TABLET, FILM COATED in 1 BOTTLE (31722-749-30)	2015-12-21	0000-00-00	No	No	Current
31722-749-31	31722074931	150 TABLET, FILM COATED in 1 CARTON (31722-749-31)	2015-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Linezolid	Coupler LLC	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	1
Linezolid	Bryant Ranch Prepack	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	103
Linezolid	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	5
Linezolid	American Health Packaging	2024-11-22	HUMAN PRESCRIPTION DRUG LABEL	6
Linezolid	REMEDYREPACK INC.	2019-04-02	HUMAN PRESCRIPTION DRUG LABEL	3