Zyvox

Product NDC: 55695-009
11-digit product format: 556950009
Labeler code: 55695
Product ID: 55695-009_2b5fe133-8101-4129-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linezolid
Dosage form: SUSPENSION
Route: ORAL
Labeler: Department of State Health Services, Pharmacy Branch
Application: NDA021132
Marketing category: NDA
Marketing start: 2000-04-18
Marketing end: 0000-00-00
Substance: LINEZOLID
Active strength: 100 mg/5mL
Pharmacologic classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	55695-009		I	Inactivated by FDA		2026-08-11
excluded package	package	55695-009	55695-009-00	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55695-009-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55695-009-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55695-009-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55695-009-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55695-009-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55695-009-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55695-009-00	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55695-009-00	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55695-009-00	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55695-009-00	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55695-009-00	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55695-009-00	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55695-009-00	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55695-009-00	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55695-009-00	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55695-009-00	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55695-009-00	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55695-009-00	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55695-009-00	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55695-009-00	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55695-009-00	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55695-009-00	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
N021132-001	ZYVOX	LINEZOLID	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021132-001	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	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`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	N021132-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021132-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021132-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021132-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021132-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021132-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021132-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021132-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021132-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021132-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021132-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021132-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021132-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021132-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021132-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021132-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021132-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021132-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021132-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021132-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021132-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021132-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021132-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021132-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021132-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021132-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021132-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021132-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021132-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021132-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021132-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021132-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021132-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021132-001	6559305	2021-01-29	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021132-001	6559305	2021-01-29	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	6559305	2021-01-29	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	6559305	2021-01-29	Drug substance	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	6559305	2021-01-29	Drug substance	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	6559305	2021-01-29	Drug substance	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	6559305	2021-01-29	Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	6559305	2021-01-29	Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	6559305	2021-01-29	Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55695-009-00	2020-01-31	C162847	48780-1	9d75b9d0-8b72-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection, tablets and oral suspension Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55695-009-00	Zyvox	240 mL in 1 BOTTLE	SUSPENSION	240		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55695-009	ZYVOX (LINEZOLID) SUSPENSION [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]	1	Legacy NDC, 1 package rows	20160311_2b5fe133-8100-4129-e054-00144ff88e88.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Mylan Pharmaceuticals Inc.	83a84897-ccca-42a1-ab1a-bbf1d43a982b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021132 application number: NDA021132
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021132 application number: NDA021132

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
311345	linezolid 100 MG in 5 mL Oral Suspension	PSN	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	ZYVOX 100 MG in 5 mL Oral Suspension	PSN	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	linezolid 20 MG/ML Oral Suspension [Zyvox]	SBD	2b5fe133-8100-4129-e054-00144ff88e88	1
311345	linezolid 20 MG/ML Oral Suspension	SCD	2b5fe133-8100-4129-e054-00144ff88e88	1
311345	linezolid 100 MG per 5 ML Oral Suspension	SY	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	Zyvox 100 MG per 5 ML Oral Suspension	SY	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	Zyvox 20 MG/ML Oral Suspension	SY	2b5fe133-8100-4129-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55695-009-00	55695000900	240 mL in 1 BOTTLE	240 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zyvox	Department of State Health Services, Pharmacy Branch	2016-02-09	HUMAN PRESCRIPTION DRUG LABEL	1