Home NDC 59762-1308 Linezolid
Product NDC 59762-1308
11-digit product format 597621308
Labeler code 59762
Product ID 59762-1308_709b7bad-813b-4e62-935a-ecde7357d391
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form SUSPENSION
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021132
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-05-18
Substance LINEZOLID
Active strength 100 mg/5mL
Pharmacologic classes Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-1308 59762-1308-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-1308 59762-1308-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021132-001 ZYVOX LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021132-001 AB
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 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 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021132-001 ZYVOX 100MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2000-04-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# 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 N021132-001 6559305 2021-01-29 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021132-001 6559305*PED 2021-07-29 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021132-001 6559305 2021-01-29 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021132-001 6559305*PED 2021-07-29 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021132-001 6559305 2021-01-29 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021132-001 6559305*PED 2021-07-29 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021132-001 6559305 2021-01-29 Drug substance 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021132-001 6559305*PED 2021-07-29 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021132-001 6559305 2021-01-29 Drug substance 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021132-001 6559305*PED 2021-07-29 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021132-001 6559305 2021-01-29 Drug substance c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021132-001 6559305*PED 2021-07-29 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021132-001 6559305 2021-01-29 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021132-001 6559305*PED 2021-07-29 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021132-001 6559305 2021-01-29 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021132-001 6559305*PED 2021-07-29 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021132-001 6559305 2021-01-29 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021132-001 6559305*PED 2021-07-29 Pediatric extension ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Linezolid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINEZOLID 100 mg/5mL
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 311345 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 59762-1308-1 Linezolid 150 mL in 1 BOTTLE SUSPENSION 150 15 59762-1308-4 Linezolid 150 mL in 1 BOTTLE SUSPENSION 150 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1308 LINEZOLID SUSPENSION [MYLAN PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 2 package rows 20250529_83a84897-ccca-42a1-ab1a-bbf1d43a982b.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 59762-1308-1 59762130801 150 mL in 1 BOTTLE (59762-1308-1) 150 ml 2015-05-18 0000-00-00 No No Current 59762-1308-4 59762130804 150 mL in 1 BOTTLE (59762-1308-4) 150 ml 2023-03-30 No No Current