Zyvox

Product NDC: 0009-5136
11-digit product format: 000095136
Labeler code: 0009
Product ID: 0009-5136_f61349cd-d7b8-4400-b433-01abcdb0cc99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linezolid
Dosage form: GRANULE, FOR SUSPENSION
Route: ORAL
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA021132
Marketing category: NDA
Marketing start: 2000-04-18
Substance: LINEZOLID
Active strength: 100 mg/5mL
Pharmacologic classes: Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0009-5136	0009-5136-01	D	Discontinued by firm		2026-08-11

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
N021132-001	ZYVOX	LINEZOLID	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021132-001	AB

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021132-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021132-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021132-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021132-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021132-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021132-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021132-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021132-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021132-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021132-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021132-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021132-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021132-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021132-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021132-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021132-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021132-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021132-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021132-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021132-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021132-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021132-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021132-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021132-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021132-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021132-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021132-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021132-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021132-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021132-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021132-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021132-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021132-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021132-001	6559305	2021-01-29	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021132-001	6559305	2021-01-29	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	6559305	2021-01-29	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	6559305	2021-01-29	Drug substance	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	6559305	2021-01-29	Drug substance	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	6559305	2021-01-29	Drug substance	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	6559305	2021-01-29	Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	6559305	2021-01-29	Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	6559305	2021-01-29	Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINEZOLID	100 mg/5mL

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 · 8 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
51fd7f50-f4ab-45ea-852e-f4101dca346b	Product name	1	20150622
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-5136-01	Zyvox	150 mL in 1 BOTTLE	GRANULE, FOR SUSPENSION	150		69
0009-5136-04	Zyvox	150 mL in 1 BOTTLE	GRANULE, FOR SUSPENSION	150		69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-5136-01	ML - Milliliter	0009-5136	8dc038d7-3a84-4b1a-80f5-0c5ec33d4f18	1	2012-07-24
0009-5136-04	ML - Milliliter	0009-5136	7e08e3d8-403d-4741-b59d-503d72c65af9	1	2023-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LINEZOLID	ACTIVE INGREDIENT	ISQ9I6J12J	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
LINEZOLID	ACTIVE MOIETY	ISQ9I6J12J	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]	33
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ZYVOX (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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-5136	ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]	64	Current NDC, Legacy NDC, 2 package rows	20240726_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Mylan Pharmaceuticals Inc.	83a84897-ccca-42a1-ab1a-bbf1d43a982b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021132 application number: NDA021132
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021132 application number: NDA021132 ndc (product): 0009-5136

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ISQ9I6J12J	LINEZOLID	165800-03-3	LINEZOLID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311345	linezolid 100 MG in 5 mL Oral Suspension	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662278	linezolid 200 MG in 100 ML Injection	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662285	linezolid 600 MG in 300 ML Injection	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
311347	linezolid 600 MG Oral Tablet	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
581614	ZYVOX 100 MG in 5 mL Oral Suspension	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662280	ZYVOX 200 MG in 100 ML Injection	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662286	ZYVOX 600 MG in 300 ML Injection	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
262091	Zyvox 600 MG Oral Tablet	PSN	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662280	100 ML linezolid 2 MG/ML Injection [Zyvox]	SBD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662286	300 ML linezolid 2 MG/ML Injection [Zyvox]	SBD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
581614	linezolid 20 MG/ML Oral Suspension [Zyvox]	SBD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
262091	linezolid 600 MG Oral Tablet [Zyvox]	SBD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662278	100 ML linezolid 2 MG/ML Injection	SCD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662285	300 ML linezolid 2 MG/ML Injection	SCD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
311345	linezolid 20 MG/ML Oral Suspension	SCD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
311347	linezolid 600 MG Oral Tablet	SCD	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662280	100 ML Zyvox 2 MG/ML Injection	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662286	300 ML Zyvox 2 MG/ML Injection	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
311345	linezolid 100 MG per 5 ML Oral Suspension	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662278	linezolid 200 MG per 100 ML Injection	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662285	linezolid 600 MG per 300 ML Injection	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
581614	Zyvox 100 MG per 5 ML Oral Suspension	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
581614	Zyvox 20 MG/ML Oral Suspension	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662280	Zyvox 200 MG per 100 ML Injection	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
262091	Zyvox 600 MG Oral Tablet	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
1662286	Zyvox 600 MG per 300 ML Injection	SY	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	69
311345	linezolid 100 MG in 5 mL Oral Suspension	PSN	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	ZYVOX 100 MG in 5 mL Oral Suspension	PSN	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	linezolid 20 MG/ML Oral Suspension [Zyvox]	SBD	2b5fe133-8100-4129-e054-00144ff88e88	1
311345	linezolid 20 MG/ML Oral Suspension	SCD	2b5fe133-8100-4129-e054-00144ff88e88	1
311345	linezolid 100 MG per 5 ML Oral Suspension	SY	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	Zyvox 100 MG per 5 ML Oral Suspension	SY	2b5fe133-8100-4129-e054-00144ff88e88	1
581614	Zyvox 20 MG/ML Oral Suspension	SY	2b5fe133-8100-4129-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-5136-01	00009513601	150 mL in 1 BOTTLE (0009-5136-01)	150 ml	2000-04-18	0000-00-00	No	No	Current
0009-5136-04	00009513604	150 mL in 1 BOTTLE (0009-5136-04)	150 ml	2023-03-27		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zyvox	Pharmacia & Upjohn Company LLC \| Pfizer Asia Manufacturing Pte Ltd \| NEOLPHARMA, INC. \| Pfizer Manufacturing Deutschland GmbH	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	72
Zyvox	Department of State Health Services, Pharmacy Branch	2016-02-09	HUMAN PRESCRIPTION DRUG LABEL	1