Oxaliplatin

Product NDC
50742-405
11-digit product format
507420405
Labeler code
50742
Product ID
50742-405_63b11eae-9347-44c8-9d99-81e81c81a140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA207562
Marketing category
ANDA
Marketing start
2018-10-29
Marketing end
0000-00-00
Substance
OXALIPLATIN
Active strength
50 mg/10mL
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-405-10ML - Milliliter50742-40503e60244-87c9-412c-ae29-7ed7d5a6ef1012019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-405OXALIPLATIN INJECTION, SOLUTION [INGENUS PHARMACEUTICALS, LLC]11Legacy NDC20231130_9613ae3d-72e2-40f7-8151-b43e915a6f1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-405-10507420405101 VIAL, SINGLE-USE in 1 CARTON (50742-405-10) > 10 mL in 1 VIAL, SINGLE-USE2018-10-290000-00-00NoNoCurrent