Linezolid

Product NDC: 67877-419
11-digit product format: 678770419
Labeler code: 67877
Product ID: 67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Linezolid
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ascend Laboratories, LLC
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: 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
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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A205517-001	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205517-001	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	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…`
2022-09-29 23:25 UTC	2022-09	A205517-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205517-001	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
7402aa01-50de-46c8-a341-d30da5b32b1c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
51fd7f50-f4ab-45ea-852e-f4101dca346b	Product name	1	20150622
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-419-01	Linezolid	100 in 1 BOTTLE	TABLET, FILM COATED	100	19
67877-419-05	Linezolid	500 in 1 BOTTLE	TABLET, FILM COATED	500	19
67877-419-10	Linezolid	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	19
67877-419-20	Linezolid	20 in 1 BOTTLE	TABLET, FILM COATED	20	19
67877-419-33	Linezolid	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	19
67877-419-33	Linezolid	1 in 1 CARTON	TABLET, FILM COATED	1	19
67877-419-38	Linezolid	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	19
67877-419-38	Linezolid	10 in 1 CARTON	TABLET, FILM COATED	10	19
67877-419-84	Linezolid	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	19
67877-419-84	Linezolid	3 in 1 CARTON	TABLET, FILM COATED	3	19
67877-419-85	Linezolid	2 in 1 CARTON	TABLET, FILM COATED	2	19
67877-419-85	Linezolid	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-419-01	EA - Each	67877-419	db8af268-f020-4dd8-95a1-7b2e3fdd9bea	1	2016-01-13
67877-419-20	EA - Each	67877-419	63f6c4e7-d4cb-4cbc-a2df-a4e93b1e69d2	1	2016-01-13
67877-419-33	EA - Each	67877-419	dce08caa-4501-41dd-bddf-4a9430309c59	1	2019-02-13
67877-419-84	EA - Each	67877-419	6c047792-3ea5-4706-a3af-ea47620c5382	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-419	LINEZOLID TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	17	Current NDC, Legacy NDC, 12 package rows	20231210_7402aa01-50de-46c8-a341-d30da5b32b1c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 67877-419

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	7402aa01-50de-46c8-a341-d30da5b32b1c	19
311347	linezolid 600 MG Oral Tablet	SCD	7402aa01-50de-46c8-a341-d30da5b32b1c	19
311347	linezolid 600 MG Oral Tablet	PSN	3e0d868d-f419-47e8-a3bc-41ececac468b	4
311347	linezolid 600 MG Oral Tablet	SCD	3e0d868d-f419-47e8-a3bc-41ececac468b	4
311347	linezolid 600 MG Oral Tablet	PSN	ab1b4ab5-7338-4b01-963b-43eeb4c9cf1c	3
311347	linezolid 600 MG Oral Tablet	SCD	ab1b4ab5-7338-4b01-963b-43eeb4c9cf1c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-419-01	67877041901	100 TABLET, FILM COATED in 1 BOTTLE (67877-419-01)		2015-12-21	0000-00-00	No	No	Current
67877-419-05	67877041905	500 TABLET, FILM COATED in 1 BOTTLE (67877-419-05)		2015-12-21	0000-00-00	No	No	Current
67877-419-10	67877041910	1000 TABLET, FILM COATED in 1 BOTTLE (67877-419-10)		2015-12-21	0000-00-00	No	No	Current
67877-419-20	67877041920	20 TABLET, FILM COATED in 1 BOTTLE (67877-419-20)		2015-12-21	0000-00-00	No	No	Current
67877-419-33	67877041933	1 BLISTER PACK in 1 CARTON (67877-419-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2015-12-21	0000-00-00	No	No	Current
67877-419-38	67877041938	10 BLISTER PACK in 1 CARTON (67877-419-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2015-12-21	0000-00-00	No	No	Current
67877-419-84	67877041984	3 BLISTER PACK in 1 CARTON (67877-419-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2015-12-21	0000-00-00	No	No	Current
67877-419-85	67877041985	2 BLISTER PACK in 1 CARTON (67877-419-85) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2015-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Linezolid	Sportpharm LLC	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Linezolid	REMEDYREPACK INC.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	5
Linezolid	Bryant Ranch Prepack	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	3
Linezolid	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2025-06-13	Human Prescription Drug Label	19