FDA.reportPublic FDA data

Oxaliplatin

Product NDC
71288-171
11-digit product format
712880171
Labeler code
71288
Product ID
71288-171_50b4c21f-714a-4a01-bf28-a856b19914d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
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
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
71288-171-11Oxaliplatin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION104
71288-171-11Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION14
71288-171-91Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION11
71288-171-91Oxaliplatin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-171-11ML - Milliliter71288-1710f5454e8-cf23-44fd-ae06-3b0a0fb5c18312025-07-08
71288-171-91ML - Milliliter71288-17159b7bb7b-1224-4529-90da-0da08635aee012025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-171OXALIPLATIN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, 2 package rows20240809_ee2e0da9-5ae7-405b-8dd1-635be72bc439.zip
71288-171OXALIPLATIN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241019_11377169-7986-45b1-8298-6f0533efa3c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSNee2e0da9-5ae7-405b-8dd1-635be72bc4394
1736776oxaliplatin 50 MG in 10 ML InjectionPSNee2e0da9-5ae7-405b-8dd1-635be72bc4394
173677610 ML oxaliplatin 5 MG/ML InjectionSCDee2e0da9-5ae7-405b-8dd1-635be72bc4394
173678120 ML oxaliplatin 5 MG/ML InjectionSCDee2e0da9-5ae7-405b-8dd1-635be72bc4394
1736781oxaliplatin 100 MG per 20 ML InjectionSYee2e0da9-5ae7-405b-8dd1-635be72bc4394
1736776oxaliplatin 50 MG per 10 ML InjectionSYee2e0da9-5ae7-405b-8dd1-635be72bc4394
1736781oxaliplatin 100 MG in 20 ML InjectionPSN11377169-7986-45b1-8298-6f0533efa3c31
1736776oxaliplatin 50 MG in 10 ML InjectionPSN11377169-7986-45b1-8298-6f0533efa3c31
173677610 ML oxaliplatin 5 MG/ML InjectionSCD11377169-7986-45b1-8298-6f0533efa3c31
173678120 ML oxaliplatin 5 MG/ML InjectionSCD11377169-7986-45b1-8298-6f0533efa3c31
1736781oxaliplatin 100 MG per 20 ML InjectionSY11377169-7986-45b1-8298-6f0533efa3c31
1736776oxaliplatin 50 MG per 10 ML InjectionSY11377169-7986-45b1-8298-6f0533efa3c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-171-11712880171111 VIAL, SINGLE-DOSE in 1 CARTON (71288-171-11) / 10 mL in 1 VIAL, SINGLE-DOSE2024-01-11NoNoCurrent
71288-171-91712880171911 VIAL, SINGLE-DOSE in 1 CARTON (71288-171-91) / 10 mL in 1 VIAL, SINGLE-DOSE2024-01-11NoNoCurrent