Zyvox
- Product NDC
- 66298-4992
- 11-digit product format
- 662984992
- Labeler code
- 66298
- Product ID
- 66298-4992_74f6ba39-466c-c32b-e053-2991aa0a665c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LINEZOLID
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi Norge As
- Application
- NDA021131
- Marketing category
- NDA
- Marketing start
- 2018-06-05
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 66298-4992 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… | ||
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66298-4992 | 66298-4992-1 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… |
Orange Book products#
| 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| ZYVOX | LINEZOLID | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2000-04-18 | |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#
| 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.
| 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#
| 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#
| Captured | Edition | Application-product | Patent | Expiration | Use code | 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… |
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.
| 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 | 021131 NDA021131 |
| Zyvox | LINEZOLID | Pharmacia & Upjohn Company LLC | 6e70e63b-bfd5-478d-a8ee-8ba22c9efabd | 2026-06-23 | Warnings, Adverse reactions | 021131 NDA021131 |
| Zyvox | LINEZOLID | Hp Halden Pharma AS | b0c75e79-bf29-4f1d-a45d-ae28398a52d9 | 2024-05-28 | Warnings, Adverse reactions | 021131 NDA021131 |
| Zyvox | LINEZOLID | Hp Halden Pharma AS | ce57225b-4580-442b-8c48-8045297cbb50 | 2024-05-28 | Warnings, Adverse reactions | 021131 NDA021131 |
| Zyvox | LINEZOLID | Hp Halden Pharma AS | efe6818c-b798-4d1d-8196-6447a305ad71 | 2024-05-28 | Warnings, Adverse reactions | 021131 NDA021131 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66298-4992-1 | 66298499201 | 300 mL in 1 BAG (66298-4992-1) | 300 ml | 2018-06-05 | 0000-00-00 | No | No | Current |