Home DailyMed 5c3877a8-e0b0-4bea-aa04-e3ccffa1c48b National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:52:41 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021131-001 ZYVOX LINEZOLID 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 N021131-002 ZYVOX LINEZOLID 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 N021131-003 ZYVOX LINEZOLID 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18
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 4 · 129 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 2026-09-14 22:38:34 2026-08 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021131-002 ZYVOX 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2000-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021131-003 ZYVOX 600MG/300ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021131-001 ZYVOX 200MG/100ML (2MG/ML) SOLUTION / INTRAVENOUS AP RLD 2000-04-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021131-001 6559305 2021-01-29 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021131-001 6559305*PED 2021-07-29 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021131-002 6559305*PED 2021-07-29 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021131-003 6559305 2021-01-29 Drug substance 2003-08-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021131-003 6559305*PED 2021-07-29 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021131-001 6559305 2021-01-29 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021131-001 6559305*PED 2021-07-29 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021131-002 6559305*PED 2021-07-29 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021131-003 6559305 2021-01-29 Drug substance 2003-08-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021131-003 6559305*PED 2021-07-29 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021131-001 6559305 2021-01-29 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021131-001 6559305*PED 2021-07-29 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021131-002 6559305*PED 2021-07-29 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021131-003 6559305 2021-01-29 Drug substance 2003-08-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021131-003 6559305*PED 2021-07-29 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021131-001 6559305 2021-01-29 Drug substance 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021131-001 6559305*PED 2021-07-29 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021131-002 6559305*PED 2021-07-29 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021131-003 6559305 2021-01-29 Drug substance 2003-08-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021131-003 6559305*PED 2021-07-29 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021131-001 6559305 2021-01-29 Drug substance 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021131-001 6559305*PED 2021-07-29 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021131-002 6559305*PED 2021-07-29 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021131-003 6559305 2021-01-29 Drug substance 2003-08-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021131-003 6559305*PED 2021-07-29 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021131-001 6559305 2021-01-29 Drug substance c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021131-001 6559305*PED 2021-07-29 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021131-002 6559305*PED 2021-07-29 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021131-003 6559305 2021-01-29 Drug substance 2003-08-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021131-003 6559305*PED 2021-07-29 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021131-001 6559305 2021-01-29 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021131-001 6559305*PED 2021-07-29 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021131-002 6559305 2021-01-29 Drug substance 2003-08-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021131-002 6559305*PED 2021-07-29 Pediatric extension 3f01610625f2…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.