Home NDC 0054-0319 Linezolid
Product NDC 0054-0319
11-digit product format 000540319
Labeler code 0054
Product ID 0054-0319_ea8ff456-80d5-4f40-b397-a25b31a77947
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA200068
Marketing category ANDA
Marketing start 2015-06-03
Substance LINEZOLID
Active strength 100 mg/5mL
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 A200068-001 LINEZOLID LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200068-001 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 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200068-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2015-06-03 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 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 0054-0319-50 Linezolid 150 mL in 1 BOTTLE POWDER, FOR SUSPENSION 150 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LINEZOLID ACTIVE INGREDIENT ISQ9I6J12J LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 LINEZOLID ACTIVE MOIETY ISQ9I6J12J LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0319 LINEZOLID POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] 16 Current NDC, Legacy NDC, 1 package rows 20250212_16007ca5-7956-4414-af38-406a6623400e.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 0054-0319-50 00054031950 150 mL in 1 BOTTLE (0054-0319-50) 150 ml 2015-06-03 0000-00-00 No No Current