Home NDC 57664-683 Linezolid
Product NDC 57664-683
11-digit product format 576640683
Labeler code 57664
Product ID 57664-683_2e599906-ac35-54ab-e063-6394a90ac605
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA207354
Marketing category ANDA
Marketing start 2017-02-01
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207354-001 LINEZOLID LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 A207354-002 LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20
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 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 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207354-001 LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207354-002 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2016-12-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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/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 1662278 Internal RxNorm lookup 1662285 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 57664-683-31 Linezolid 300 mL in 1 BAG INJECTION, SOLUTION 300 19 57664-683-57 Linezolid 10 in 1 BOX INJECTION, SOLUTION 10 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-683 LINEZOLID INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20250221_870c9600-04d5-4b44-a5b5-02252a310f22.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 · 1 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 57664-683-31 57664068331 300 mL in 1 BAG 300 ml Historical 57664-683-57 57664068357 10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31) 10 bag 2017-02-01 0000-00-00 No No Current