FDA.reportPublic FDA data

Oxaliplatin

Product NDC
61703-363
11-digit product format
617030363
Labeler code
61703
Product ID
61703-363_ecdfccf3-58e8-47ce-89d3-53a4d3e3af21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXALIPLATIN
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA078813
Marketing category
ANDA
Marketing start
2009-08-10
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0364c41f-a4ea-b691-2739-986f76e794e5Product name920190125
b153e9b5-916b-4df6-8413-d22b82f1d312Product name220170720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61703-363-18Oxaliplatin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE1017
61703-363-18Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE117
61703-363-22Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE117
61703-363-22Oxaliplatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-363-18ML - Milliliter61703-363b20993d3-5d3b-4122-8104-b1324881bc2d12012-07-24
61703-363-22ML - Milliliter61703-363d5d3cde1-46eb-4885-9b8e-118e9cc524f112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXALIPLATINACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]4
OXALIPLATINACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-363OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]17Current NDC, Legacy NDC, 4 package rows20240927_e51a62ba-d163-4c57-835c-8c86cf097e40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNe51a62ba-d163-4c57-835c-8c86cf097e4017
1736776oxaliplatin 50 MG in 10 ML InjectionPSNe51a62ba-d163-4c57-835c-8c86cf097e4017
173677610 ML oxaliplatin 5 MG/ML InjectionSCDe51a62ba-d163-4c57-835c-8c86cf097e4017
173678120 ML oxaliplatin 5 MG/ML InjectionSCDe51a62ba-d163-4c57-835c-8c86cf097e4017
1736781oxaliplatin 100 MG per 20 ML InjectionSYe51a62ba-d163-4c57-835c-8c86cf097e4017
1736776oxaliplatin 50 MG per 10 ML InjectionSYe51a62ba-d163-4c57-835c-8c86cf097e4017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-363-18617030363181 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18) / 10 mL in 1 VIAL, SINGLE-DOSE2009-08-100000-00-00NoNoCurrent
61703-363-22617030363221 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSE2009-08-100000-00-00NoNoCurrent