oxaliplatin

Product NDC
25021-233
11-digit product format
250210233
Labeler code
25021
Product ID
25021-233_c159050a-e588-4091-b9ee-ea502e1b9529
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA203869
Marketing category
ANDA
Marketing start
2014-09-15
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
25021-233-10oxaliplatin1 in 1 CARTONINJECTION, SOLUTION18
25021-233-10oxaliplatin10 mL in 1 VIALINJECTION, SOLUTION108
25021-233-20oxaliplatin20 mL in 1 VIALINJECTION, SOLUTION208
25021-233-20oxaliplatin1 in 1 CARTONINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-233-10ML - Milliliter25021-233892b5f5f-d174-46aa-90ee-619d0e3c9a1c12014-10-03
25021-233-20ML - Milliliter25021-2334a116fe1-4612-4256-95d5-b56ceabac10412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxaliplatinACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
oxaliplatinACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IOXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
tartaric acidINACTIVE INGREDIENTW4888I119HOXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
waterINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-233OXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]7Current NDC, Legacy NDC, 4 package rows20231217_29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSN29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f8
1736776oxaliplatin 50 MG in 10 ML InjectionPSN29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f8
173677610 ML oxaliplatin 5 MG/ML InjectionSCD29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f8
173678120 ML oxaliplatin 5 MG/ML InjectionSCD29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f8
1736781oxaliplatin 100 MG per 20 ML InjectionSY29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f8
1736776oxaliplatin 50 MG per 10 ML InjectionSY29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-233-10250210233101 VIAL in 1 CARTON (25021-233-10) / 10 mL in 1 VIAL1 vial2014-09-150000-00-00NoNoCurrent
25021-233-20250210233201 VIAL in 1 CARTON (25021-233-20) / 20 mL in 1 VIAL1 vial2014-09-150000-00-00NoNoCurrent