Home NDC 0955-1727 OXALIPLATIN
Product NDC 0955-1727
11-digit product format 009551727
Labeler code 0955
Product ID 0955-1727_dfd7b336-3bf2-43e1-8197-06d85be3fe11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxaliplatin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Winthrop U.S.
Application NDA021759
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-07-07
Marketing end 0000-00-00
Substance OXALIPLATIN
Active strength 5 mg/mL
Pharmacologic classes Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0955-1727-20 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0955-1727-20 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0955-1727-20 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0955-1727-20 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0955-1727-20 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0955-1727-20 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0955-1727-20 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0955-1727-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0955-1727-20 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021759-001 ELOXATIN OXALIPLATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 N021759-002 ELOXATIN OXALIPLATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 N021759-003 ELOXATIN OXALIPLATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17
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 4 · 132 observed 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 2026-10-15 13:18:30 2026-09 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021759-003 ELOXATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0955-1727 OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] 16 Legacy NDC 20231208_a98b4070-822f-4fba-a844-690ff5556f0b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0955-1727-20 00955172720 1 VIAL, GLASS in 1 CARTON (0955-1727-20) > 20 mL in 1 VIAL, GLASS 2014-07-07 0000-00-00 No No Current