FDA.reportPublic FDA data

Oxaliplatin

Product NDC
60505-6287
11-digit product format
605056287
Labeler code
60505
Product ID
60505-6287_e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA204368
Marketing category
ANDA
Marketing start
2024-04-23
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
60505-6287-2Oxaliplatin10 mL in 1 VIALINJECTION, SOLUTION102
60505-6287-2Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION12
60505-6287-4Oxaliplatin20 mL in 1 VIALINJECTION, SOLUTION202
60505-6287-4Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6287-2ML - Milliliter60505-628769e9a3b7-14de-4f61-94f7-0a0ac66b8ab712024-05-16
60505-6287-4ML - Milliliter60505-6287b2b048b8-0376-439b-b368-f8687a76e17512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6287OXALIPLATIN INJECTION, SOLUTION [APOTEX CORP.]1Current NDC, 4 package rows20240424_bb180ec5-1f75-43c1-9f63-c0657af2ca5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNbb180ec5-1f75-43c1-9f63-c0657af2ca5f2
1736776oxaliplatin 50 MG in 10 ML InjectionPSNbb180ec5-1f75-43c1-9f63-c0657af2ca5f2
173677610 ML oxaliplatin 5 MG/ML InjectionSCDbb180ec5-1f75-43c1-9f63-c0657af2ca5f2
173678120 ML oxaliplatin 5 MG/ML InjectionSCDbb180ec5-1f75-43c1-9f63-c0657af2ca5f2
1736781oxaliplatin 100 MG per 20 ML InjectionSYbb180ec5-1f75-43c1-9f63-c0657af2ca5f2
1736776oxaliplatin 50 MG per 10 ML InjectionSYbb180ec5-1f75-43c1-9f63-c0657af2ca5f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-6287-2605056287021 VIAL in 1 CARTON (60505-6287-2) / 10 mL in 1 VIAL1 vial2024-04-23NoNoCurrent
60505-6287-4605056287041 VIAL in 1 CARTON (60505-6287-4) / 20 mL in 1 VIAL1 vial2024-04-23NoNoCurrent