Home NDC 33342-352 Linezolid
Product NDC 33342-352
11-digit product format 333420352
Labeler code 33342
Product ID 33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linezolid
Dosage form TABLET, COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA210378
Marketing category ANDA
Marketing start 2024-10-10
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 A210378-001 LINEZOLID LINEZOLID 600MG TABLET / ORAL 2024-10-10
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 A210378-001 LINEZOLID 600MG TABLET / ORAL 2024-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210378-001 LINEZOLID 600MG TABLET / ORAL 2024-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210378-001 LINEZOLID 600MG TABLET / ORAL 2024-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210378-001 LINEZOLID 600MG TABLET / ORAL AB 2024-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210378-001 LINEZOLID 600MG TABLET / ORAL AB 2024-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210378-001 LINEZOLID 600MG TABLET / ORAL AB 2024-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210378-001 LINEZOLID 600MG TABLET / ORAL AB 2024-10-10 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210378-001 LINEZOLID 600MG TABLET / ORAL AB 2024-10-10 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210378-001 LINEZOLID 600MG TABLET / ORAL 2024-10-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210378-001 AB 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210378-001 AB 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210378-001 AB 1 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210378-001 AB 1 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210378-001 AB 1 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Linezolid
Listing expiration 2027-12-31 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 33342-352-11 Linezolid 100 in 1 BOTTLE TABLET, COATED 100 1 33342-352-31 Linezolid 10 in 1 BLISTER PACK TABLET, COATED 10 1 33342-352-31 Linezolid 5 in 1 CARTON TABLET, COATED 5 1 33342-352-32 Linezolid 20 in 1 BOTTLE TABLET, COATED 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-352 LINEZOLID TABLET, COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20241129_90dd8c13-c428-4472-91e5-5b1fcdc4fce3.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 Sample Exclude flag Status 33342-352-06 33342035206 3 BLISTER PACK in 1 CARTON (33342-352-06) / 10 TABLET, COATED in 1 BLISTER PACK (33342-352-66) 3 blister pack 2026-07-22 0 Current 33342-352-11 33342035211 100 TABLET, COATED in 1 BOTTLE (33342-352-11) 2024-10-10 No No Current 33342-352-31 33342035231 5 BLISTER PACK in 1 CARTON (33342-352-31) / 10 TABLET, COATED in 1 BLISTER PACK 5 blister pack 2024-10-10 No No Current 33342-352-32 33342035232 20 TABLET, COATED in 1 BOTTLE (33342-352-32) 2024-10-10 No No Current