Home NDC 42677-336 oxaliplatin
Product NDC 42677-336
11-digit product format 426770336
Labeler code 42677
Product ID 42677-336_4f6846af-385e-b624-e063-6394a90a28d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxaliplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Shandong New Time Pharmaceutical Co., Ltd.
Application ANDA219765
Marketing category ANDA
Marketing start 2026-01-15
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 A219765-001 OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-01-15 A219765-002 OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-01-15
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 A219765-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219765-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-01-15 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219765-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-01-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219765-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-01-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219765-001 AP 1 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219765-002 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219765-001 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219765-002 AP 1 a50c72e98297…
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 42677-336-01 oxaliplatin 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 2 42677-336-10 oxaliplatin 10 in 1 CARTON INJECTION, SOLUTION 10 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join oxaliplatin OXALIPLATIN Shandong New Time Pharmaceutical Co., Ltd. 1ac38523-480b-4c0f-97a1-7dfa1432923c 2026-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219765 application number: ANDA219765 ndc (product): 42677-336
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42677-336-01 42677033601 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 42677-336-10 42677033610 10 VIAL, SINGLE-DOSE in 1 CARTON (42677-336-10) / 10 mL in 1 VIAL, SINGLE-DOSE (42677-336-01) 2026-01-15 No No Current