Oxaliplatin

Product NDC
72603-101
11-digit product format
726030101
Labeler code
72603
Product ID
72603-101_f7b91231-4045-45a6-97c3-72fa9deaccf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA207325
Marketing category
ANDA
Marketing start
2019-06-17
Marketing end
2027-03-31
Substance
OXALIPLATIN
Active strength
5 mg/mL
Pharmacologic classes
Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaliplatin

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
72603-101-01Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION17
72603-101-01Oxaliplatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-101-01ML - Milliliter72603-10153e90de7-a00d-49d3-b551-d2cde7d6ea8c12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-101OXALIPLATIN INJECTION, SOLUTION [NORTHSTAR RX LLC]6Current NDC, Legacy NDC, 2 package rows20240224_f299b2d2-86ed-4fb8-822e-65455a0bb75a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNf299b2d2-86ed-4fb8-822e-65455a0bb75a7
1736776oxaliplatin 50 MG in 10 ML InjectionPSNf299b2d2-86ed-4fb8-822e-65455a0bb75a7
173677610 ML oxaliplatin 5 MG/ML InjectionSCDf299b2d2-86ed-4fb8-822e-65455a0bb75a7
173678120 ML oxaliplatin 5 MG/ML InjectionSCDf299b2d2-86ed-4fb8-822e-65455a0bb75a7
1736781oxaliplatin 100 MG per 20 ML InjectionSYf299b2d2-86ed-4fb8-822e-65455a0bb75a7
1736776oxaliplatin 50 MG per 10 ML InjectionSYf299b2d2-86ed-4fb8-822e-65455a0bb75a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72603-101-01726030101011 VIAL, SINGLE-DOSE in 1 CARTON (72603-101-01) / 20 mL in 1 VIAL, SINGLE-DOSE2019-06-172027-03-31NoNoCurrent