OXALIPLATIN

Product NDC
0955-1727
11-digit product format
009551727
Labeler code
0955
Product ID
0955-1727_dfd7b336-3bf2-43e1-8197-06d85be3fe11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxaliplatin
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Winthrop U.S.
Application
NDA021759
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-07-07
Marketing end
0000-00-00
Substance
OXALIPLATIN
Active strength
5 mg/mL
Pharmacologic classes
Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0955-1727-202025-08-25C16284748780-12cef2736-a327-d83d-e063-dadaa90ab31fa98b4070-822f-4fba-a844-690ff5556f0b
0955-1727-202025-01-30C16284748780-12cef2736-a327-d83d-e063-dadaa90ab31fa98b4070-822f-4fba-a844-690ff5556f0b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1727-20ML - Milliliter0955-1727e97398b8-ab37-491c-a2c4-85a42a70955a12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxaliplatinACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]5
oxaliplatinACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]5
WaterINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1727OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]16Legacy NDC20231208_a98b4070-822f-4fba-a844-690ff5556f0b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0955-1727-20009551727201 VIAL, GLASS in 1 CARTON (0955-1727-20) > 20 mL in 1 VIAL, GLASS2014-07-070000-00-00NoNoCurrent