Home NDC 25021-233-20 oxaliplatin
Product NDC 25021-233
Requested package NDC 25021-233-20
11-digit product format 250210233
Labeler code 25021
Product ID 25021-233_c159050a-e588-4091-b9ee-ea502e1b9529
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxaliplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA203869
Marketing category ANDA
Marketing start 2014-09-15
Substance OXALIPLATIN
Active strength 5 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 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 A203869-001 OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS 2014-06-18 A203869-002 OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS 2014-06-18
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 2026-08-01 22:54:32 2026-06 A203869-001 OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE / INTRAVENOUS 2014-06-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A203869-002 OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE / INTRAVENOUS 2014-06-18 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base oxaliplatin
Listing expiration 2026-12-31 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 25021-233-10 oxaliplatin 1 in 1 CARTON INJECTION, SOLUTION 1 8 25021-233-10 oxaliplatin 10 mL in 1 VIAL INJECTION, SOLUTION 10 8 25021-233-20 oxaliplatin 20 mL in 1 VIAL INJECTION, SOLUTION 20 8 25021-233-20 oxaliplatin 1 in 1 CARTON INJECTION, SOLUTION 1 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-233 OXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 Current NDC, Legacy NDC, 4 package rows 20231217_29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f.zip
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 25021-233-20 25021023320 1 VIAL in 1 CARTON (25021-233-20) / 20 mL in 1 VIAL 1 vial 2014-09-15 0000-00-00 No No Current