FDA.reportPublic FDA data

Linezolid

Product NDC
68382-413
11-digit product format
683820413
Labeler code
68382
Product ID
68382-413_936ad52c-acf7-45da-9c28-7cf85e61fcdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206097
Marketing category
ANDA
Marketing start
2017-08-09
Marketing end
0000-00-00
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-413DDiscontinued by firm2026-07-31
excluded packagepackage68382-41368382-413-01DDiscontinued by firm2026-07-31
excluded packagepackage68382-41368382-413-05DDiscontinued by firm2026-07-31
excluded packagepackage68382-41368382-413-06DDiscontinued by firm2026-07-31
excluded packagepackage68382-41368382-413-10DDiscontinued by firm2026-07-31
excluded packagepackage68382-41368382-413-16DDiscontinued by firm2026-07-31
excluded packagepackage68382-41368382-413-92DDiscontinued by firm2026-07-31

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
A206097-001LINEZOLIDLINEZOLID600MGTABLET / ORALAB2017-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206097-001AB

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
2026-08-01 22:54:322026-06A206097-001LINEZOLID600MGTABLET / ORALAB2017-02-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206097-001AB1a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-413-0168382041301100 TABLET, FILM COATED in 1 BOTTLE (68382-413-01) 2017-08-090000-00-00NoNoCurrent
68382-413-0568382041305500 TABLET, FILM COATED in 1 BOTTLE (68382-413-05) 2017-08-090000-00-00NoNoCurrent
68382-413-066838204130630 TABLET, FILM COATED in 1 BOTTLE (68382-413-06) 2017-08-090000-00-00NoNoCurrent
68382-413-10683820413101000 TABLET, FILM COATED in 1 BOTTLE (68382-413-10) 2017-08-090000-00-00NoNoCurrent
68382-413-166838204131690 TABLET, FILM COATED in 1 BOTTLE (68382-413-16) 2017-08-090000-00-00NoNoCurrent
68382-413-926838204139220 TABLET, FILM COATED in 1 BOTTLE (68382-413-92) 2017-08-090000-00-00NoNoCurrent