Home NDC 59762-1307-2 Linezolid
Product NDC 59762-1307
Requested package NDC 59762-1307-2
11-digit product format 597621307
Labeler code 59762
Product ID 59762-1307_c553c285-1954-4f89-8988-3bada9c4a65e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linezolid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021130
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-10-12
Marketing end 2026-08-31
Substance LINEZOLID
Active strength 600 mg/1
Pharmacologic classes Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag No
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Approval date N021130-001 ZYVOX LINEZOLID 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 N021130-002 ZYVOX LINEZOLID 600MG TABLET / ORAL RLD 2000-04-18
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 2026-08-01 22:54:32 2026-06 N021130-001 ZYVOX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N021130-002 ZYVOX 600MG TABLET / ORAL RLD 2000-04-18 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Linezolid 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 59762-1307-1 Linezolid 20 in 1 BOTTLE TABLET, FILM COATED 20 16 59762-1307-2 Linezolid 1 in 1 BLISTER PACK TABLET, FILM COATED 1 16 59762-1307-2 Linezolid 20 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 20 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1307 LINEZOLID TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 3 package rows 20250529_374af2a7-d994-40bd-a86a-cd9038d0b72c.zip
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 59762-1307-2 59762130702 20 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK 20 blister pack 2015-10-12 2026-08-31 No No Current