linezolid

Product NDC: 25021-169
11-digit product format: 250210169
Labeler code: 25021
Product ID: 25021-169_af251e92-89af-4f35-9c7c-924d92af17d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linezolid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA204696
Marketing category: ANDA
Marketing start: 2017-08-15
Marketing end: 0000-00-00
Substance: LINEZOLID
Active strength: 2 mg/mL
Pharmacologic classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	25021-169		D	Discontinued by firm		2026-07-31
excluded package	package	25021-169	25021-169-87	D	Discontinued by firm		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204696-001	LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-03-02
A204696-002	LINEZOLID	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204696-001	AP
A204696-002	AP

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.

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
2026-08-01 22:54:32	2026-06	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-03-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-03-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204696-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204696-002	AP	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-169-87	ML - Milliliter	25021-169	79278433-aa4a-4eba-bd93-4aca577a202c	1	2018-08-13

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-169-87	25021016987	10 BAG in 1 CARTON (25021-169-87) > 300 mL in 1 BAG	10 bag	2017-08-15	0000-00-00	No	No	Current