Home NDC 72603-420 Oxaliplatin
Product NDC 72603-420
11-digit product format 726030420
Labeler code 72603
Product ID 72603-420_9ebe158f-dd21-4bb8-ac13-d18162773cef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaliplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Northstar Rx LLC
Application ANDA217348
Marketing category ANDA
Marketing start 2024-01-11
Substance OXALIPLATIN
Active strength 5 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217348-001 OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 A217348-002 OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11
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.
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 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217348-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217348-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Oxaliplatin
Listing expiration 2027-12-31 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 72603-420-01 Oxaliplatin 1 in 1 CARTON INJECTION, SOLUTION 1 5 72603-420-01 Oxaliplatin 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-420 OXALIPLATIN INJECTION, SOLUTION [NORTHSTAR RX LLC] 2 Current NDC, 2 package rows 20241019_7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6.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 · 3 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 72603-420-01 72603042001 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-420-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2024-01-11 No No Current