Zyvox

Product NDC
0009-5140
11-digit product format
000095140
Labeler code
0009
Product ID
0009-5140_f61349cd-d7b8-4400-b433-01abcdb0cc99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA021131
Marketing category
NDA
Marketing start
2000-04-18
Substance
LINEZOLID
Active strength
600 mg/300mL
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021131-001ZYVOXLINEZOLID200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18
N021131-002ZYVOXLINEZOLID400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18
N021131-003ZYVOXLINEZOLID600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021131-001AP
N021131-003AP

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021131-002ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2000-04-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021131-003ZYVOX600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2000-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021131-001ZYVOX200MG/100ML (2MG/ML)SOLUTION / INTRAVENOUSAPRLD2000-04-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021131-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021131-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021131-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021131-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021131-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021131-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021131-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021131-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021131-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021131-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021131-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021131-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021131-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021131-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021131-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021131-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021131-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021131-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021131-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021131-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021131-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021131-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021131-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021131-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021131-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021131-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021131-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021131-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021131-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021131-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021131-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021131-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021131-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021131-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021131-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021131-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021131-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021131-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021131-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021131-003AP1782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021131-00165593052021-01-29Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021131-0016559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021131-00265593052021-01-29Drug substance2003-08-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021131-0026559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021131-00365593052021-01-29Drug substance2003-08-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021131-0036559305*PED2021-07-29Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021131-00165593052021-01-29Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021131-0016559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021131-00265593052021-01-29Drug substance2003-08-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N021131-0026559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021131-00365593052021-01-29Drug substance2003-08-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N021131-0036559305*PED2021-07-29Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021131-00165593052021-01-29Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021131-0016559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021131-00265593052021-01-29Drug substance2003-08-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021131-0026559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021131-00365593052021-01-29Drug substance2003-08-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021131-0036559305*PED2021-07-29Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021131-00165593052021-01-29Drug substance5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021131-0016559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021131-00265593052021-01-29Drug substance2003-08-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021131-0026559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021131-00365593052021-01-29Drug substance2003-08-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021131-0036559305*PED2021-07-29Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021131-00165593052021-01-29Drug substance8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021131-0016559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021131-00265593052021-01-29Drug substance2003-08-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021131-0026559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021131-00365593052021-01-29Drug substance2003-08-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021131-0036559305*PED2021-07-29Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021131-00165593052021-01-29Drug substancec0c555d07b60…
2020-11-12 02:37 UTC2020-11N021131-0016559305*PED2021-07-29Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021131-00265593052021-01-29Drug substance2003-08-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021131-0026559305*PED2021-07-29Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021131-00365593052021-01-29Drug substance2003-08-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021131-0036559305*PED2021-07-29Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021131-00165593052021-01-29Drug substance3f01610625f2…
2019-12-14 00:12 UTC2019-12N021131-0016559305*PED2021-07-29Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021131-00265593052021-01-29Drug substance2003-08-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021131-0026559305*PED2021-07-29Pediatric extension3f01610625f2…

Additional Listing Data#

Finished product
Yes
Brand name base
Zyvox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID600 mg/300mL

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
0009-5140-01Zyvox300 mL in 1 BAGINJECTION, SOLUTION30069
0009-5140-04Zyvox10 in 1 BOXINJECTION, SOLUTION1069

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-5140-01ML - Milliliter0009-51405c3877a8-e0b0-4bea-aa04-e3ccffa1c48b12012-07-24
0009-5140-04ML - Milliliter0009-51404b3b2471-2321-441e-9340-24e9fe2477fe12015-05-05

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
0009-5140ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]64Current NDC, Legacy NDC, 2 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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC3e5e9975-6f36-42e4-ab46-0e75dda835922026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 021131
application number: NDA021131
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC6e70e63b-bfd5-478d-a8ee-8ba22c9efabd2026-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021131
application number: NDA021131
ndc (product): 0009-5140
ZyvoxLINEZOLIDHp Halden Pharma ASb0c75e79-bf29-4f1d-a45d-ae28398a52d92024-05-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021131
application number: NDA021131
ZyvoxLINEZOLIDHp Halden Pharma ASce57225b-4580-442b-8c48-8045297cbb502024-05-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021131
application number: NDA021131
ZyvoxLINEZOLIDHp Halden Pharma ASefe6818c-b798-4d1d-8196-6447a305ad712024-05-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021131
application number: NDA021131

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
0009-5140-0100009514001300 mL in 1 BAG300 mlHistorical
0009-5140-040000951400410 BAG in 1 BOX (0009-5140-04) / 300 mL in 1 BAG (0009-5140-01) 10 bag2000-04-180000-00-00NoNoCurrent