Home NDC 68083-171 Oxaliplatin
Product NDC 68083-171
11-digit product format 680830171
Labeler code 68083
Product ID 68083-171_0d039035-85d1-40d4-8ee6-540026ab7a5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxaliplatin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA207385
Marketing category ANDA
Marketing start 2017-05-29
Substance OXALIPLATIN
Active strength 100 mg/20mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207385-001 OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 A207385-002 OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23
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 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207385-001 OXALIPLATIN 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207385-002 OXALIPLATIN 100MG/VIAL INJECTABLE / INTRAVENOUS AP 2017-05-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 100 mg/20mL
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 1736784 Internal RxNorm lookup 1736786 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 68083-171-01 Oxaliplatin 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-171 OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 1 package rows 20170529_d6178bc6-9dae-413f-8f47-de75d576c5b8.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.
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 68083-171-01 68083017101 20 mL in 1 VIAL (68083-171-01) 20 ml 2017-05-29 0000-00-00 No No Current