Home NDC 59762-1307 Linezolid
Product NDC 59762-1307
11-digit product format 597621307
Labeler code 59762
Product ID 59762-1307_c553c285-1954-4f89-8988-3bada9c4a65e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021130
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-10-12
Marketing end 2026-08-31
Substance LINEZOLID
Active strength 600 mg/1
Pharmacologic classes Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag No
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 · 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Approval date N021130-001 ZYVOX LINEZOLID 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 N021130-002 ZYVOX LINEZOLID 600MG TABLET / ORAL RLD 2000-04-18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 · 82 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UTC 2026-02 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021130-002 ZYVOX 600MG TABLET / ORAL RLD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of this ZIP 2025-12 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021130-002 ZYVOX 600MG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…2022-03-09 01:35 UTC 2022-03 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 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 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 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021130-002 ZYVOX 600MG TABLET / ORAL AB RLD, RS 2000-04-18 782e0a99824c…
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…
Additional Listing Data#
Finished product Yes
Brand name base Linezolid Active Ingredients# Ingredient, Strength table Ingredient Strength LINEZOLID 600 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311347 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 59762-1307-1 Linezolid 20 in 1 BOTTLE TABLET, FILM COATED 20 16 59762-1307-2 Linezolid 1 in 1 BLISTER PACK TABLET, FILM COATED 1 16 59762-1307-2 Linezolid 20 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 20 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1307 LINEZOLID TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 3 package rows 20250529_374af2a7-d994-40bd-a86a-cd9038d0b72c.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.
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 59762-1307-1 59762130701 20 TABLET, FILM COATED in 1 BOTTLE (59762-1307-1) 2015-10-12 0000-00-00 No No Current 59762-1307-2 59762130702 20 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK 20 blister pack 2015-10-12 2026-08-31 No No Current