Zyvox

Product NDC
0009-5138
11-digit product format
000095138
Labeler code
0009
Product ID
0009-5138_f61349cd-d7b8-4400-b433-01abcdb0cc99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA021130
Marketing category
NDA
Marketing start
2015-10-12
Marketing end
2027-02-28
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0009-51380009-5138-03DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0009-51380009-5138-03DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0009-51380009-5138-03DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021130-001ZYVOXLINEZOLID400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18
N021130-002ZYVOXLINEZOLID600MGTABLET / ORALRLD2000-04-18

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021130-002ZYVOX600MGTABLET / ORALRLD2000-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021130-002ZYVOX600MGTABLET / ORALRLD2000-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD2000-04-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021130-001ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD2000-04-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-002ZYVOX600MGTABLET / ORALABRLD, RS2000-04-18782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N021130-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021130-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021130-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021130-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021130-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021130-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021130-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021130-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021130-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021130-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021130-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021130-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021130-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021130-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021130-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021130-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021130-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021130-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021130-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021130-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021130-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021130-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021130-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021130-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021130-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021130-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021130-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021130-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021130-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021130-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021130-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021130-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021130-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021130-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021130-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021130-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021130-002AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021130-00165593052021-01-29Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-00165145292021-03-15Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0016559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0016514529*PED2021-09-15Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-00265593052021-01-29Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-00265145292021-03-15Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0026559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021130-0026514529*PED2021-09-15Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021130-00165593052021-01-29Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-00165145292021-03-15Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0016559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0016514529*PED2021-09-15Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-00265593052021-01-29Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-00265145292021-03-15Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0026559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021130-0026514529*PED2021-09-15Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00165593052021-01-29Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00165145292021-03-15Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0016559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0016514529*PED2021-09-15Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00265593052021-01-29Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-00265145292021-03-15Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0026559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021130-0026514529*PED2021-09-15Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021130-00165593052021-01-29Drug substance5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-00165145292021-03-15Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0016559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0016514529*PED2021-09-15Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-00265593052021-01-29Drug substance5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-00265145292021-03-15Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0026559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021130-0026514529*PED2021-09-15Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021130-00165593052021-01-29Drug substance8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-00165145292021-03-15Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0016559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0016514529*PED2021-09-15Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-00265593052021-01-29Drug substance8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-00265145292021-03-15Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0026559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021130-0026514529*PED2021-09-15Pediatric extension8869cabd3fbd…

Additional Listing Data#

Finished product
Yes
Brand name base
Zyvox

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ISQ9I6J12JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
262091Internal RxNorm lookup
311345Internal RxNorm lookup
311347Internal RxNorm lookup
581614Internal RxNorm lookup
1662278Internal RxNorm lookup
1662280Internal RxNorm lookup
1662285Internal RxNorm lookup
1662286Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e70e63b-bfd5-478d-a8ee-8ba22c9efabdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-5138-02Zyvox20 in 1 BOTTLETABLET, FILM COATED2069
0009-5138-03Zyvox1 in 1 BLISTER PACKTABLET, FILM COATED169
0009-5138-03Zyvox30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3069

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-5138-02EA - Each0009-5138f09c0876-2963-4272-8451-ef1412e460ce12015-11-12
0009-5138-03EA - Each0009-513867d47854-74d4-4a88-a137-fc4efbf5033312015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LINEZOLIDACTIVE INGREDIENTISQ9I6J12JZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
LINEZOLIDACTIVE MOIETYISQ9I6J12JZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
MANNITOLINACTIVE INGREDIENT3OWL53L36AZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SUCROSEINACTIVE INGREDIENTC151H8M554ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-5138ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]64Current NDC, Legacy NDC, 3 package rows20240726_6e70e63b-bfd5-478d-a8ee-8ba22c9efabd.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LinezolidLINEZOLIDMylan Pharmaceuticals Inc.374af2a7-d994-40bd-a86a-cd9038d0b72c2026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 021130
application number: NDA021130
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC6e70e63b-bfd5-478d-a8ee-8ba22c9efabd2026-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021130
application number: NDA021130
ndc (product): 0009-5138

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311345linezolid 100 MG in 5 mL Oral SuspensionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662278linezolid 200 MG in 100 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662285linezolid 600 MG in 300 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311347linezolid 600 MG Oral TabletPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614ZYVOX 100 MG in 5 mL Oral SuspensionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280ZYVOX 200 MG in 100 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286ZYVOX 600 MG in 300 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
262091Zyvox 600 MG Oral TabletPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280100 ML linezolid 2 MG/ML Injection [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286300 ML linezolid 2 MG/ML Injection [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614linezolid 20 MG/ML Oral Suspension [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
262091linezolid 600 MG Oral Tablet [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662278100 ML linezolid 2 MG/ML InjectionSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662285300 ML linezolid 2 MG/ML InjectionSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311345linezolid 20 MG/ML Oral SuspensionSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311347linezolid 600 MG Oral TabletSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280100 ML Zyvox 2 MG/ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286300 ML Zyvox 2 MG/ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311345linezolid 100 MG per 5 ML Oral SuspensionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662278linezolid 200 MG per 100 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662285linezolid 600 MG per 300 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614Zyvox 100 MG per 5 ML Oral SuspensionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614Zyvox 20 MG/ML Oral SuspensionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280Zyvox 200 MG per 100 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
262091Zyvox 600 MG Oral TabletSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286Zyvox 600 MG per 300 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-5138-020000951380220 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02) 2015-10-122027-02-28NoNoCurrent
0009-5138-030000951380330 BLISTER PACK in 1 BOX, UNIT-DOSE (0009-5138-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2015-10-120000-00-00NoNoCurrent