Zyvox

Product NDC: 0009-4992
11-digit product format: 000094992
Labeler code: 0009
Product ID: 0009-4992_dadada4c-83d4-4526-8341-9df1fd642f63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linezolid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA021131
Marketing category: NDA
Marketing start: 2015-07-06
Marketing end: 0000-00-00
Substance: LINEZOLID
Active strength: 600 mg/300mL
Pharmacologic classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0009-4992		D	Discontinued by firm		2026-08-11
excluded package	package	0009-4992	0009-4992-02	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0009-4992		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0009-4992	0009-4992-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021131-001	ZYVOX	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18
N021131-002	ZYVOX	LINEZOLID	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18
N021131-003	ZYVOX	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021131-001	AP
N021131-003	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 4 · 123 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	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`8072bd15b7f6…`

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	N021131-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021131-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021131-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021131-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021131-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021131-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021131-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021131-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021131-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021131-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021131-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021131-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021131-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021131-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021131-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021131-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021131-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021131-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-003	AP	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021131-001	6559305	2021-01-29	Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021131-001	6559305	2021-01-29	Drug substance		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-001	6559305	2021-01-29	Drug substance		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021131-001	6559305	2021-01-29	Drug substance		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021131-001	6559305	2021-01-29	Drug substance		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021131-001	6559305	2021-01-29	Drug substance		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021131-001	6559305	2021-01-29	Drug substance		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`3f01610625f2…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-4992-01	ML - Milliliter	0009-4992	945520bb-42d6-4bc5-b214-1b4bdb6ab0d3	1	2015-07-20
0009-4992-02	ML - Milliliter	0009-4992	8bf0063f-36f6-49f5-86fa-575fcc22188c	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LINEZOLID	ACTIVE INGREDIENT	ISQ9I6J12J	ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	4
LINEZOLID	ACTIVE MOIETY	ISQ9I6J12J	ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	4
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-4992	ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]	21	Legacy NDC	20240927_122faa9e-c71a-4597-9552-5fb330b7d8b9.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
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	3e5e9975-6f36-42e4-ab46-0e75dda83592	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131
Zyvox	LINEZOLID	Hp Halden Pharma AS	b0c75e79-bf29-4f1d-a45d-ae28398a52d9	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131
Zyvox	LINEZOLID	Hp Halden Pharma AS	ce57225b-4580-442b-8c48-8045297cbb50	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131
Zyvox	LINEZOLID	Hp Halden Pharma AS	efe6818c-b798-4d1d-8196-6447a305ad71	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-4992-02	00009499202	10 BAG in 1 BOX (0009-4992-02) > 300 mL in 1 BAG (0009-4992-01)	10 bag	2015-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zyvox	Pharmacia & Upjohn Company LLC \| HP Halden Pharma AS \| Pfizer Asia Manufacturing Pte Ltd \| Pfizer Inc \| Pfizer Laboratories Div Pfizer Inc \| Symed Labs Limited	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL	22