Home NDC 0143-9534 Linezolid
Product NDC 0143-9534
11-digit product format 001439534
Labeler code 0143
Product ID 0143-9534_22fd37ba-a112-4fb2-a595-d571232c792e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linezolid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA206454
Marketing category ANDA
Marketing start 2022-12-27
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206454-001 LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206454-001 AP
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.
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 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206454-001 LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0143-9534-10 Linezolid 10 in 1 BOX INJECTION, SOLUTION 10 12 0143-9534-10 Linezolid 1 in 1 POUCH INJECTION, SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9534 LINEZOLID INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 2 package rows 20240824_fedbffa7-087d-4448-85c9-0350a3947080.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 0143-9534-10 00143953410 10 POUCH in 1 BOX (0143-9534-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG 10 pouch 2022-12-27 0000-00-00 No No Current