Oxaliplatin

Product NDC
0781-3317
11-digit product format
007813317
Labeler code
0781
Product ID
0781-3317_f3766495-fce3-461c-8c95-e890f5e3383f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA078817
Marketing category
ANDA
Marketing start
2015-03-01
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
0781-3317-80Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION112
0781-3317-80Oxaliplatin20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3317-80ML - Milliliter0781-3317dc105f57-2284-42ce-92a9-30b9d0a37e0612015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXALIPLATINACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION [SANDOZ INC]5
OXALIPLATINACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION [SANDOZ INC]5
WATERINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION [SANDOZ INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3317OXALIPLATIN INJECTION, SOLUTION [SANDOZ INC]12Current NDC, Legacy NDC, 2 package rows20250130_ab162009-6f84-4d56-ab56-5e84409ec814.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNab162009-6f84-4d56-ab56-5e84409ec81412
1736776oxaliplatin 50 MG in 10 ML InjectionPSNab162009-6f84-4d56-ab56-5e84409ec81412
173677610 ML oxaliplatin 5 MG/ML InjectionSCDab162009-6f84-4d56-ab56-5e84409ec81412
173678120 ML oxaliplatin 5 MG/ML InjectionSCDab162009-6f84-4d56-ab56-5e84409ec81412
1736781oxaliplatin 100 MG per 20 ML InjectionSYab162009-6f84-4d56-ab56-5e84409ec81412
1736776oxaliplatin 50 MG per 10 ML InjectionSYab162009-6f84-4d56-ab56-5e84409ec81412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3317-80007813317801 VIAL, SINGLE-USE in 1 CARTON (0781-3317-80) / 20 mL in 1 VIAL, SINGLE-USE2015-03-010000-00-00NoNoCurrent