FDA.reportPublic FDA data

Oxaliplatin

Product NDC
63323-750
11-digit product format
633230750
Labeler code
63323
Product ID
63323-750_504bf43e-4c28-4375-a6f4-285b2357f7f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA078811
Marketing category
ANDA
Marketing start
2010-06-11
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
63323-750-10Oxaliplatin1 in 1 BOXINJECTION, SOLUTION, CONCENTRATE115
63323-750-10Oxaliplatin10 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE1015
63323-750-20Oxaliplatin1 in 1 BOXINJECTION, SOLUTION, CONCENTRATE115
63323-750-20Oxaliplatin20 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-750-10ML - Milliliter63323-750d4912e28-a839-4566-b897-f5114649a74b12015-08-04
63323-750-20ML - Milliliter63323-75024a0a2f2-9786-47b7-b980-f60d693af43f12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXALIPLATINACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC]10
OXALIPLATINACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC]10
WATERINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-750OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC ]14Current NDC, Legacy NDC, 4 package rows20211020_e12e2850-4980-48de-af58-15e559fb921f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNe12e2850-4980-48de-af58-15e559fb921f15
1736776oxaliplatin 50 MG in 10 ML InjectionPSNe12e2850-4980-48de-af58-15e559fb921f15
173677610 ML oxaliplatin 5 MG/ML InjectionSCDe12e2850-4980-48de-af58-15e559fb921f15
173678120 ML oxaliplatin 5 MG/ML InjectionSCDe12e2850-4980-48de-af58-15e559fb921f15
1736781oxaliplatin 100 MG per 20 ML InjectionSYe12e2850-4980-48de-af58-15e559fb921f15
1736776oxaliplatin 50 MG per 10 ML InjectionSYe12e2850-4980-48de-af58-15e559fb921f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-750-10633230750101 VIAL in 1 BOX (63323-750-10) > 10 mL in 1 VIAL1 vial2010-06-110000-00-00NoNoCurrent
63323-750-20633230750201 VIAL in 1 BOX (63323-750-20) > 20 mL in 1 VIAL1 vial2010-06-110000-00-00NoNoCurrent