Home NDC 70518-1226 Zyvox
Product NDC 70518-1226
11-digit product format 705181226
Labeler code 70518
Product ID 70518-1226_e34aea86-535f-3d10-e053-2995a90af840
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021130
Marketing category NDA
Marketing start 2018-06-08
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 2023-12-31
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.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021130-001 ZYVOX LINEZOLID 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 N021130-002 ZYVOX LINEZOLID 600MG TABLET / ORAL RLD 2000-04-18
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 · 86 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 2026-09-14 22:38:34 2026-08 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021130-002 ZYVOX 600MG TABLET / ORAL RLD 2000-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021130-002 ZYVOX 600MG TABLET / ORAL RLD 2000-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021130-002 ZYVOX 600MG TABLET / ORAL RLD 2000-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021130-002 ZYVOX 600MG TABLET / ORAL RLD 2000-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2000-04-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021130-001 6559305 2021-01-29 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-001 6514529 2021-03-15 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-001 6559305*PED 2021-07-29 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-001 6514529*PED 2021-09-15 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-002 6559305 2021-01-29 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-002 6514529 2021-03-15 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-002 6559305*PED 2021-07-29 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021130-002 6514529*PED 2021-09-15 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021130-001 6559305 2021-01-29 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-001 6514529 2021-03-15 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-001 6559305*PED 2021-07-29 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-001 6514529*PED 2021-09-15 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-002 6559305 2021-01-29 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-002 6514529 2021-03-15 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-002 6559305*PED 2021-07-29 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-002 6514529*PED 2021-09-15 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-001 6559305 2021-01-29 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-001 6514529 2021-03-15 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-001 6559305*PED 2021-07-29 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-001 6514529*PED 2021-09-15 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-002 6559305 2021-01-29 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-002 6514529 2021-03-15 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-002 6559305*PED 2021-07-29 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021130-002 6514529*PED 2021-09-15 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021130-001 6559305 2021-01-29 Drug substance 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-001 6514529 2021-03-15 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-001 6559305*PED 2021-07-29 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-001 6514529*PED 2021-09-15 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-002 6559305 2021-01-29 Drug substance 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-002 6514529 2021-03-15 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-002 6559305*PED 2021-07-29 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021130-002 6514529*PED 2021-09-15 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021130-001 6559305 2021-01-29 Drug substance 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-001 6514529 2021-03-15 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-001 6559305*PED 2021-07-29 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-001 6514529*PED 2021-09-15 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-002 6559305 2021-01-29 Drug substance 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-002 6514529 2021-03-15 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-002 6559305*PED 2021-07-29 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021130-002 6514529*PED 2021-09-15 Pediatric extension 8869cabd3fbd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zyvox LINEZOLID Pharmacia & Upjohn Company LLC 6e70e63b-bfd5-478d-a8ee-8ba22c9efabd 2026-06-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 021130 application number: NDA021130
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-1226-1 70518122601 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1226-1) 2019-12-24 0000-00-00 No No Current