FDA.reportPublic FDA data

Linezolid

Product NDC
65145-181
11-digit product format
651450181
Labeler code
65145
Product ID
65145-181_2220c753-e0e8-4797-bce2-34b3c63bd631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA219558
Marketing category
ANDA
Marketing start
2025-12-23
Substance
LINEZOLID
Active strength
600 mg/300mL
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219558-001LINEZOLIDLINEZOLID600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAP2025-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219558-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219558-001LINEZOLID600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAP2025-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219558-001LINEZOLID600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAP2025-12-0831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219558-001LINEZOLID600MG/300ML (2MG/ML)SOLUTION / INTRAVENOUSAP2025-12-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219558-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219558-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219558-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Linezolid
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1662285Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2220c753-e0e8-4797-bce2-34b3c63bd631Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-181-01Linezolid300 mL in 1 BAGINJECTION, SOLUTION3001
65145-181-01Linezolid1 in 1 POUCHINJECTION, SOLUTION11
65145-181-10Linezolid10 in 1 CASEINJECTION, SOLUTION101

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LinezolidLINEZOLIDCaplin Steriles Limited2220c753-e0e8-4797-bce2-34b3c63bd6312025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219558
application number: ANDA219558
ndc (product): 65145-181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSN2220c753-e0e8-4797-bce2-34b3c63bd6311
1662285300 ML linezolid 2 MG/ML InjectionSCD2220c753-e0e8-4797-bce2-34b3c63bd6311
1662285linezolid 600 MG per 300 ML InjectionSY2220c753-e0e8-4797-bce2-34b3c63bd6311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-181-0165145018101300 mL in 1 BAG300 mlHistorical
65145-181-106514501811010 POUCH in 1 CASE (65145-181-10) / 1 BAG in 1 POUCH (65145-181-01) / 300 mL in 1 BAG10 pouch2025-12-23NoNoCurrent