Home NDC 0955-1733 OXALIPLATIN
Product NDC 0955-1733
11-digit product format 009551733
Labeler code 0955
Product ID 0955-1733_0bef8406-8dab-0ad0-e063-6394a90a60d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxaliplatin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Winthrop U.S, a business of sanofi-aventis U.S. LLC
Application NDA021759
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-09-01
Substance OXALIPLATIN
Active strength 5 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
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 · 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ELOXATIN OXALIPLATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 N021759-002 ELOXATIN OXALIPLATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 N021759-003 ELOXATIN OXALIPLATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-11-17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 · 123 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 2026-02-19 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2026-02 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021759-002 ELOXATIN 100MG/20ML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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 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 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2005-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 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 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021759-002 ELOXATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 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 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021759-001 ELOXATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-01-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OXALIPLATIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXALIPLATIN 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04ZR38536J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1736776 Internal RxNorm lookup 1736781 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 0955-1733-20 OXALIPLATIN 20 mL in 1 VIAL, GLASS INJECTION, SOLUTION, CONCENTRATE 20 10 0955-1733-20 OXALIPLATIN 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0955-1733 OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] 10 Current NDC, Legacy NDC, 2 package rows 20231208_70269278-fe61-4800-a064-32cb6845cc28.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OXALIPLATIN OXALIPLATIN Winthrop U.S, a business of sanofi-aventis U.S. LLC 70269278-fe61-4800-a064-32cb6845cc28 2023-12-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021759 application number: NDA021759 ndc (product): 0955-1733
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0955-1733-20 00955173320 1 VIAL, GLASS in 1 CARTON (0955-1733-20) / 20 mL in 1 VIAL, GLASS 2015-09-01 0000-00-00 No No Current