Oxaliplatin

Product NDC
43066-018
11-digit product format
430660018
Labeler code
43066
Product ID
43066-018_e6815a98-0efc-4d69-8612-9e7ab7e78c0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA078817
Marketing category
ANDA
Marketing start
2018-02-19
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
43066-018-01Oxaliplatin20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION207
43066-018-01Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-018-01ML - Milliliter43066-01882824d8f-655f-4ee4-be7f-c5f52352070012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-018OXALIPLATIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7Current NDC, Legacy NDC, 2 package rows20250130_21a2bb1d-d91d-4f99-97dd-cc67fe99a090.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSN21a2bb1d-d91d-4f99-97dd-cc67fe99a0907
1736776oxaliplatin 50 MG in 10 ML InjectionPSN21a2bb1d-d91d-4f99-97dd-cc67fe99a0907
173677610 ML oxaliplatin 5 MG/ML InjectionSCD21a2bb1d-d91d-4f99-97dd-cc67fe99a0907
173678120 ML oxaliplatin 5 MG/ML InjectionSCD21a2bb1d-d91d-4f99-97dd-cc67fe99a0907
1736781oxaliplatin 100 MG per 20 ML InjectionSY21a2bb1d-d91d-4f99-97dd-cc67fe99a0907
1736776oxaliplatin 50 MG per 10 ML InjectionSY21a2bb1d-d91d-4f99-97dd-cc67fe99a0907

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43066-018-01430660018011 VIAL, SINGLE-USE in 1 CARTON (43066-018-01) / 20 mL in 1 VIAL, SINGLE-USE2018-02-190000-00-00NoNoCurrent