linezolid

Product NDC
32228-003
11-digit product format
322280003
Labeler code
32228
Product ID
32228-003_83b8c309-0df2-4a02-88f2-586d5602b642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
TABLET
Route
ORAL
Labeler
Celltrion, Inc.
Application
ANDA210702
Marketing category
ANDA
Marketing start
2019-04-25
Marketing end
0000-00-00
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct32228-003DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-01DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-02DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-03DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-04DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-05DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-06DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-07DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-08DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-09DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-10DDiscontinued by firm2026-08-07
excluded packagepackage32228-00332228-003-11DDiscontinued by firm2026-08-07

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 3 · 144 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 packagepackage32228-003-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage32228-003-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage32228-003-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage32228-003-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage32228-003-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage32228-003-08cfe11265f3b6…090c488252e2…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210702-001LINEZOLIDLINEZOLID600MGTABLET / ORALAB2019-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210702-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-253f01610625f2…
2019-09-15 20:21 UTC2019-09A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210702-001LINEZOLID600MGTABLET / ORALAB2019-04-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210702-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210702-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210702-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210702-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210702-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210702-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210702-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210702-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210702-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210702-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210702-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210702-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210702-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210702-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210702-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210702-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210702-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210702-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210702-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210702-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210702-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210702-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210702-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210702-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210702-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210702-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210702-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210702-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210702-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210702-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210702-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210702-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210702-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210702-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210702-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210702-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210702-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210702-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210702-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210702-001AB1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
linezolidLINEZOLIDChartwell RX, LLC9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210702
application number: ANDA210702