Home NDC 66298-5140 Zyvox
Product NDC 66298-5140
11-digit product format 662985140
Labeler code 66298
Product ID 66298-5140_19883774-59a8-7251-e063-6294a90a3f5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hp Halden Pharma AS
Application NDA021131
Marketing category NDA
Marketing start 2018-06-05
Substance LINEZOLID
Active strength 600 mg/300mL
Pharmacologic classes Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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N021131-002 ZYVOX LINEZOLID 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 N021131-003 ZYVOX LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS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# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 123 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 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2026-02 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021131-003 ZYVOX 600MG/300ML (2MG/ML)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# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 54 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 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…
Additional Listing Data#
Finished product Yes
Brand name base Zyvox
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINEZOLID 600 mg/300mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ISQ9I6J12J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1662285 Internal RxNorm lookup 1662286 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66298-5140-1 Zyvox 300 mL in 1 BAG INJECTION, SOLUTION 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66298-5140 ZYVOX (LINEZOLID) INJECTION, SOLUTION [HP HALDEN PHARMA AS] 4 Current NDC, Legacy NDC, 1 package rows 20240530_efe6818c-b798-4d1d-8196-6447a305ad71.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66298-5140-1 66298514001 300 mL in 1 BAG (66298-5140-1) 300 ml 2018-06-05 0000-00-00 No No Current