Home NDC 60687-309 Linezolid
Product NDC 60687-309
11-digit product format 606870309
Labeler code 60687
Product ID 60687-309_278685f1-7b24-ea7e-e063-6394a90a9713
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linezolid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA204239
Marketing category ANDA
Marketing start 2018-02-15
Substance LINEZOLID
Active strength 600 mg/1
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204239-001 LINEZOLID LINEZOLID 600MG TABLET / ORAL AB 2015-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204239-001 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 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204239-001 LINEZOLID 600MG TABLET / ORAL AB 2015-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Linezolid
Listing expiration 2026-12-31 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 60687-309-11 Linezolid 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 60687-309-21 Linezolid 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-309 LINEZOLID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 6 Current NDC, Legacy NDC, 2 package rows 20241124_bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c.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 · 4 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 60687-309-11 60687030911 1 in 1 BLISTER PACK Historical 60687-309-21 60687030921 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-309-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-309-11) 30 blister pack 2018-02-15 0000-00-00 No No Current