FDA.reportPublic FDA data

Oxaliplatin

Product NDC
71288-101
11-digit product format
712880101
Labeler code
71288
Product ID
71288-101_d6861b65-5f18-4217-91b5-132425791d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA207325
Marketing category
ANDA
Marketing start
2017-10-01
Marketing end
2027-02-28
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
71288-101-10Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION16
71288-101-10Oxaliplatin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
71288-101-20Oxaliplatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION206
71288-101-20Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-101-10ML - Milliliter71288-1014386693c-5523-4341-b364-6e28d389864c12017-11-06
71288-101-20ML - Milliliter71288-1017d4950b0-fb4c-4745-853a-94aec433560f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-101OXALIPLATIN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20240628_873fa936-157a-4f85-bc70-5df31d71d122.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSN873fa936-157a-4f85-bc70-5df31d71d1226
1736776oxaliplatin 50 MG in 10 ML InjectionPSN873fa936-157a-4f85-bc70-5df31d71d1226
173677610 ML oxaliplatin 5 MG/ML InjectionSCD873fa936-157a-4f85-bc70-5df31d71d1226
173678120 ML oxaliplatin 5 MG/ML InjectionSCD873fa936-157a-4f85-bc70-5df31d71d1226
1736781oxaliplatin 100 MG per 20 ML InjectionSY873fa936-157a-4f85-bc70-5df31d71d1226
1736776oxaliplatin 50 MG per 10 ML InjectionSY873fa936-157a-4f85-bc70-5df31d71d1226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-101-10712880101101 VIAL, SINGLE-DOSE in 1 CARTON (71288-101-10) / 10 mL in 1 VIAL, SINGLE-DOSE2017-10-012027-02-28NoNoCurrent
71288-101-20712880101201 VIAL, SINGLE-DOSE in 1 CARTON (71288-101-20) / 20 mL in 1 VIAL, SINGLE-DOSE2017-10-012027-02-28NoNoCurrent