Linezolid

Product NDC: 0409-4883
11-digit product format: 004094883
Labeler code: 0409
Product ID: 0409-4883_6cd59961-fd78-4d62-bf0d-a42a02f10e48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LINEZOLID
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA206473
Marketing category: NDA
Marketing start: 2015-06-18
Substance: LINEZOLID
Active strength: 2 mg/mL
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	0409-4883	0409-4883-01	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
N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-06-18

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINEZOLID	2 mg/mL

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
1662285	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
c401f1a8-cc37-461b-bfef-f2e156629bf8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
780e0a7c-a57b-4ddb-82c2-fdccbc11064a	Product name	9	20170814
51fd7f50-f4ab-45ea-852e-f4101dca346b	Product name	1	20150622

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-4883-01	Linezolid	1 in 1 POUCH	INJECTION, SOLUTION	1	20
0409-4883-01	Linezolid	10 in 1 CASE	INJECTION, SOLUTION	10	20
0409-4883-03	Linezolid	300 mL in 1 BAG	INJECTION, SOLUTION	300	20
0409-4883-10	Linezolid	10 in 1 CASE	INJECTION, SOLUTION	10	20
0409-4883-10	Linezolid	1 in 1 POUCH	INJECTION, SOLUTION	1	20
0409-4883-11	Linezolid	300 mL in 1 BAG	INJECTION, SOLUTION	300	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-4883-01	ML - Milliliter	0409-4883	950fb9a1-2a9a-484b-a68d-eb0f335ce70a	1	2015-07-20
0409-4883-03	ML - Milliliter	0409-4883	f18c2e38-3b0f-455b-a255-2ba9e35b28a5	1	2023-07-06
0409-4883-10	ML - Milliliter	0409-4883	5412bfdc-08bd-455f-8a08-5f01a02cf1cd	1	2023-07-06
0409-4883-11	ML - Milliliter	0409-4883	10a830b7-4c1d-4a69-9a37-81a3ab78b181	1	2019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LINEZOLID	ACTIVE INGREDIENT	ISQ9I6J12J	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1
LINEZOLID	ACTIVE MOIETY	ISQ9I6J12J	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-4883	LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]	18	Current NDC, Legacy NDC, 6 package rows	20250508_c401f1a8-cc37-461b-bfef-f2e156629bf8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Hospira, Inc.	c401f1a8-cc37-461b-bfef-f2e156629bf8	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206473 application number: NDA206473 ndc (product): 0409-4883

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
1662285	linezolid 600 MG in 300 ML Injection	PSN	c401f1a8-cc37-461b-bfef-f2e156629bf8	20
1662285	300 ML linezolid 2 MG/ML Injection	SCD	c401f1a8-cc37-461b-bfef-f2e156629bf8	20
1662285	linezolid 600 MG per 300 ML Injection	SY	c401f1a8-cc37-461b-bfef-f2e156629bf8	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-4883-01	00409488301	10 POUCH in 1 CASE (0409-4883-01) > 1 BAG in 1 POUCH > 300 mL in 1 BAG (0409-4883-11)	10 pouch	2015-06-18	0000-00-00	No	No	Current
0409-4883-03	00409488303	300 mL in 1 BAG	300 ml					Historical
0409-4883-10	00409488310	10 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03)	10 pouch	2023-06-19		No	No	Current
0409-4883-11	00409488311	300 mL in 1 BAG	300 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Linezolid	Hospira, Inc. \| Pfizer Asia Manufacturing Pte Ltd	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	21