Zyvox

Product NDC
21695-399
11-digit product format
216950399
Labeler code
21695
Product ID
21695-399_50630775-7f76-413e-9278-ba298dd7f187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021130
Marketing category
NDA
Marketing start
2000-04-18
Marketing end
0000-00-00
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-399IInactivated by FDA2026-08-11
excluded packagepackage21695-39921695-399-20IInactivated by FDA2026-08-11

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-399-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-399-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-399-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-399-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-399-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-399-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-399-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-399-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-399-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-399-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-399-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-399-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-399-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-399-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-399-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-399-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-399-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-399-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-399-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-399-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-399-209bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-399-20110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021130-001ZYVOXLINEZOLID400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18
N021130-002ZYVOXLINEZOLID600MGTABLET / ORALRLD2000-04-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021130-002ZYVOX600MGTABLET / ORALRLD2000-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021130-002ZYVOX600MGTABLET / ORALRLD2000-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD2000-04-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD2000-04-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N021130-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021130-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021130-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021130-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021130-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021130-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021130-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021130-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021130-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021130-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021130-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021130-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021130-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021130-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021130-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021130-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021130-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021130-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021130-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021130-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021130-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021130-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021130-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021130-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021130-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021130-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021130-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021130-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021130-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021130-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021130-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021130-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021130-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021130-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021130-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021130-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021130-002AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021130-00165593052021-01-29Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-00165145292021-03-15Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0016559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0016514529*PED2021-09-15Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-00265593052021-01-29Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-00265145292021-03-15Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0026559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0026514529*PED2021-09-15Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021130-00165593052021-01-29Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-00165145292021-03-15Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0016559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0016514529*PED2021-09-15Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-00265593052021-01-29Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-00265145292021-03-15Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0026559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0026514529*PED2021-09-15Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00165593052021-01-29Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00165145292021-03-15Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0016559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0016514529*PED2021-09-15Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00265593052021-01-29Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00265145292021-03-15Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0026559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0026514529*PED2021-09-15Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021130-00165593052021-01-29Drug substance5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-00165145292021-03-15Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0016559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0016514529*PED2021-09-15Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-00265593052021-01-29Drug substance5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-00265145292021-03-15Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0026559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0026514529*PED2021-09-15Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021130-00165593052021-01-29Drug substance8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-00165145292021-03-15Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0016559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0016514529*PED2021-09-15Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-00265593052021-01-29Drug substance8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-00265145292021-03-15Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0026559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0026514529*PED2021-09-15Pediatric extension8869cabd3fbd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-399-202019-09-24C16284748780-1934fe258-4953-48b1-e053-8cdaa90a720aZYVOX ® (linezolid) injection (linezolid) tablets (linezolid) for oral suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-399-20Zyvox20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-399-20EA - Each21695-39919e1623d-ccd7-48d3-83da-f959e4a1e8c912013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-399ZYVOX (LINEZOLID) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110127_50630775-7f76-413e-9278-ba298dd7f187.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LinezolidLINEZOLIDMylan Pharmaceuticals Inc.374af2a7-d994-40bd-a86a-cd9038d0b72c2026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 021130
application number: NDA021130
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC6e70e63b-bfd5-478d-a8ee-8ba22c9efabd2026-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021130
application number: NDA021130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN50630775-7f76-413e-9278-ba298dd7f1871
262091Zyvox 600 MG Oral TabletPSN50630775-7f76-413e-9278-ba298dd7f1871
262091linezolid 600 MG Oral Tablet [Zyvox]SBD50630775-7f76-413e-9278-ba298dd7f1871
311347linezolid 600 MG Oral TabletSCD50630775-7f76-413e-9278-ba298dd7f1871
262091Zyvox 600 MG Oral TabletSY50630775-7f76-413e-9278-ba298dd7f1871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-399-202169503992020 in 1 BOTTLEHistorical