Home NDC 63323-750 Oxaliplatin
Product NDC 63323-750
11-digit product format 633230750
Labeler code 63323
Product ID 63323-750_504bf43e-4c28-4375-a6f4-285b2357f7f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaliplatin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA078811
Marketing category ANDA
Marketing start 2010-06-11
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63323-750 63323-750-20 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63323-750 63323-750-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078811-001 OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 A078811-002 OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078811-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078811-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2010-06-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-750-10 Oxaliplatin 1 in 1 BOX INJECTION, SOLUTION, CONCENTRATE 1 15 63323-750-10 Oxaliplatin 10 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 10 15 63323-750-20 Oxaliplatin 1 in 1 BOX INJECTION, SOLUTION, CONCENTRATE 1 15 63323-750-20 Oxaliplatin 20 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 20 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXALIPLATIN ACTIVE INGREDIENT 04ZR38536J OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 10 OXALIPLATIN ACTIVE MOIETY 04ZR38536J OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 10 WATER INACTIVE INGREDIENT 059QF0KO0R OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-750 OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC
] 14 Current NDC, Legacy NDC, 4 package rows 20211020_e12e2850-4980-48de-af58-15e559fb921f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-750-10 63323075010 1 VIAL in 1 BOX (63323-750-10) > 10 mL in 1 VIAL 1 vial 2010-06-11 0000-00-00 No No Current 63323-750-20 63323075020 1 VIAL in 1 BOX (63323-750-20) > 20 mL in 1 VIAL 1 vial 2010-06-11 0000-00-00 No No Current