Oxaliplatin

Product NDC
68001-468
11-digit product format
680010468
Labeler code
68001
Product ID
68001-468_2ee49254-54a3-0865-e063-6294a90a2974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA204368
Marketing category
ANDA
Marketing start
2020-12-09
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
68001-468-36Oxaliplatin10 mL in 1 VIALINJECTION, SOLUTION107
68001-468-36Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION17
68001-468-37Oxaliplatin20 mL in 1 VIALINJECTION, SOLUTION207
68001-468-37Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-468-36ML - Milliliter68001-46849b34447-9956-47f3-887e-d29bd074cc3612021-02-05
68001-468-37ML - Milliliter68001-46886518349-0401-4b87-bff5-1a5fac8ca12112021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-468OXALIPLATIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 4 package rows20250226_b6083405-9b45-4d2c-e053-2995a90ad9ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNb6083405-9b45-4d2c-e053-2995a90ad9ef7
1736776oxaliplatin 50 MG in 10 ML InjectionPSNb6083405-9b45-4d2c-e053-2995a90ad9ef7
173677610 ML oxaliplatin 5 MG/ML InjectionSCDb6083405-9b45-4d2c-e053-2995a90ad9ef7
173678120 ML oxaliplatin 5 MG/ML InjectionSCDb6083405-9b45-4d2c-e053-2995a90ad9ef7
1736781oxaliplatin 100 MG per 20 ML InjectionSYb6083405-9b45-4d2c-e053-2995a90ad9ef7
1736776oxaliplatin 50 MG per 10 ML InjectionSYb6083405-9b45-4d2c-e053-2995a90ad9ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-468-36680010468361 VIAL in 1 CARTON (68001-468-36) / 10 mL in 1 VIAL1 vial2020-12-090000-00-00NoNoCurrent
68001-468-37680010468371 VIAL in 1 CARTON (68001-468-37) / 20 mL in 1 VIAL1 vial2020-12-090000-00-00NoNoCurrent