Home NDC 60687-754 Linezolid
Product NDC 60687-754
11-digit product format 606870754
Labeler code 60687
Product ID 60687-754_03380d95-6c5f-1701-e063-6294a90abb95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linezolid
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler American Health Packaging
Application ANDA211813
Marketing category ANDA
Marketing start 2023-08-20
Substance LINEZOLID
Active strength 100 mg/5mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211813-001 LINEZOLID LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211813-001 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.
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 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Linezolid
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311345 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-754-05 Linezolid 150 mL in 1 BOTTLE, GLASS GRANULE, FOR SUSPENSION 150 1 60687-754-05 Linezolid 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-754 LINEZOLID GRANULE, FOR SUSPENSION [AMERICAN HEALTH PACKAGING] 1 Current NDC, 2 package rows 20230820_e9ac1ad7-7a23-463d-a467-f0ecc7e523e7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60687-754-05 60687075405 1 BOTTLE, GLASS in 1 CARTON (60687-754-05) / 150 mL in 1 BOTTLE, GLASS 2023-08-20 No No Current