Oxaliplatin

Product NDC
72603-420
11-digit product format
726030420
Labeler code
72603
Product ID
72603-420_9ebe158f-dd21-4bb8-ac13-d18162773cef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA217348
Marketing category
ANDA
Marketing start
2024-01-11
Substance
OXALIPLATIN
Active strength
5 mg/mL
Pharmacologic classes
Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaliplatin
Listing expiration
2027-12-31

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
72603-420-01Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION15
72603-420-01Oxaliplatin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-420-01ML - Milliliter72603-420e1e4e9b3-c903-40c7-94c6-50716129884412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-420OXALIPLATIN INJECTION, SOLUTION [NORTHSTAR RX LLC]2Current NDC, 2 package rows20241019_7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSN7dc8dfb1-dec8-43b3-b2ea-05eac054b2c65
1736776oxaliplatin 50 MG in 10 ML InjectionPSN7dc8dfb1-dec8-43b3-b2ea-05eac054b2c65
173677610 ML oxaliplatin 5 MG/ML InjectionSCD7dc8dfb1-dec8-43b3-b2ea-05eac054b2c65
173678120 ML oxaliplatin 5 MG/ML InjectionSCD7dc8dfb1-dec8-43b3-b2ea-05eac054b2c65
1736781oxaliplatin 100 MG per 20 ML InjectionSY7dc8dfb1-dec8-43b3-b2ea-05eac054b2c65
1736776oxaliplatin 50 MG per 10 ML InjectionSY7dc8dfb1-dec8-43b3-b2ea-05eac054b2c65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-420-01726030420011 VIAL, SINGLE-DOSE in 1 CARTON (72603-420-01) / 10 mL in 1 VIAL, SINGLE-DOSE2024-01-11NoNoHistorical