Oxaliplatin

Product NDC
50742-406
11-digit product format
507420406
Labeler code
50742
Product ID
50742-406_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
100 mg/20mL
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
50742-406-20ML - Milliliter50742-4061f3b4e2c-a788-42f1-945b-50cdd72d953612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-406OXALIPLATIN 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
50742-406-20507420406201 VIAL, SINGLE-USE in 1 CARTON (50742-406-20) > 20 mL in 1 VIAL, SINGLE-USE2018-10-290000-00-00NoNoCurrent