Home NDC 67184-0508 Oxaliplatin
Product NDC 67184-0508
11-digit product format 671840508
Labeler code 67184
Product ID 67184-0508_e78605b3-b28b-4634-9a58-d4bda67832ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxaliplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA204368
Marketing category ANDA
Marketing start 2016-06-07
Substance OXALIPLATIN
Active strength 50 mg/10mL
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 A204368-001 OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 A204368-002 OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 A204368-003 OXALIPLATIN OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07
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 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 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204368-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204368-003 OXALIPLATIN 200MG/40ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2016-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204368-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2016-06-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 50 mg/10mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1736776 Internal RxNorm lookup 1736781 Internal RxNorm lookup 1797528 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 67184-0508-1 Oxaliplatin 1 in 1 CARTON INJECTION, SOLUTION 1 7 67184-0508-1 Oxaliplatin 10 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67184-0508 OXALIPLATIN INJECTION, SOLUTION OXALIPLATIN INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] 7 Current NDC, Legacy NDC, 2 package rows 20241116_33d4f4b4-bb4e-46af-9e89-df20154436d0.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxaliplatin OXALIPLATIN BluePoint Laboratories b6083405-9b45-4d2c-e053-2995a90ad9ef 2025-02-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204368 application number: ANDA204368 Oxaliplatin OXALIPLATIN Qilu Pharmaceutical Co., Ltd. 33d4f4b4-bb4e-46af-9e89-df20154436d0 2024-11-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204368 application number: ANDA204368 ndc (product): 67184-0508 Oxaliplatin OXALIPLATIN Apotex Corp. ee5a5a1d-63f6-4d5a-901b-65be45ec6610 2024-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204368 application number: ANDA204368 Oxaliplatin OXALIPLATIN Apotex Corp. bb180ec5-1f75-43c1-9f63-c0657af2ca5f 2024-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204368 application number: ANDA204368
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 67184-0508-1 67184050801 1 VIAL, SINGLE-USE in 1 CARTON (67184-0508-1) / 10 mL in 1 VIAL, SINGLE-USE 2016-06-07 0000-00-00 No No Current