Home NDC 0703-3986-01 Oxaliplatin
Product NDC 0703-3986
Requested package NDC 0703-3986-01
11-digit product format 007033986
Labeler code 0703
Product ID 0703-3986_ef9edd2b-00c3-4faf-8083-354d0f363357
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaliplatin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application NDA022160
Marketing category NDA
Marketing start 2009-08-11
Marketing end 0000-00-00
Substance OXALIPLATIN
Active strength 100 mg/20mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 N022160-001 OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2009-08-07 N022160-002 OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD 2009-08-07
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 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022160-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022160-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2009-08-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXALIPLATIN ACTIVE INGREDIENT 04ZR38536J OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 6 OXALIPLATIN ACTIVE MOIETY 04ZR38536J OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-3986 OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 14 Legacy NDC 20241103_9e51cc79-620c-48d7-b267-78e43c1ef6e4.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-3986-01 00703398601 1 VIAL, SINGLE-USE in 1 CARTON (0703-3986-01) > 20 mL in 1 VIAL, SINGLE-USE 2009-08-11 0000-00-00 No No Current