Oxaliplatin

Product NDC
67457-442
11-digit product format
674570442
Labeler code
67457
Product ID
67457-442_01a705c0-0014-4a63-aa66-918cdcc2df67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA091358
Marketing category
ANDA
Marketing start
2014-05-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaliplatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXALIPLATIN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04ZR38536J
Rxcui1736776, 1736781

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0364c41f-a4ea-b691-2739-986f76e794e5Product name920190125
b153e9b5-916b-4df6-8413-d22b82f1d312Product name220170720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-442-20Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION16
67457-442-20Oxaliplatin20 mL in 1 VIALINJECTION, SOLUTION206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-442-20ML - Milliliter67457-4428f3eb11c-303e-43d5-9798-74a413c2e43512014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXALIPLATINACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
OXALIPLATINACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
WATERINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-442OXALIPLATIN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5Current NDC, Legacy NDC, 2 package rows20240530_da0e8523-609a-4326-96b1-d7de78662d91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNda0e8523-609a-4326-96b1-d7de78662d916
1736776oxaliplatin 50 MG in 10 ML InjectionPSNda0e8523-609a-4326-96b1-d7de78662d916
173677610 ML oxaliplatin 5 MG/ML InjectionSCDda0e8523-609a-4326-96b1-d7de78662d916
173678120 ML oxaliplatin 5 MG/ML InjectionSCDda0e8523-609a-4326-96b1-d7de78662d916
1736781oxaliplatin 100 MG per 20 ML InjectionSYda0e8523-609a-4326-96b1-d7de78662d916
1736776oxaliplatin 50 MG per 10 ML InjectionSYda0e8523-609a-4326-96b1-d7de78662d916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-442-20674570442201 VIAL in 1 CARTON (67457-442-20) / 20 mL in 1 VIAL1 vial2014-05-160000-00-00NoNoCurrent