CARBOPLATIN

Product NDC
55150-333
11-digit product format
551500333
Labeler code
55150
Product ID
55150-333_6029d051-ee8d-44cc-8dae-b91c3385d4c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPLATIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205487
Marketing category
ANDA
Marketing start
2016-09-29
Substance
CARBOPLATIN
Active strength
50 mg/5mL
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
CARBOPLATIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOPLATIN50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBG3F62OND5
Rxcui597195

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5428ef-b189-45ae-a76c-39765d009ff4Product name320170502

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-333-01CARBOPLATIN5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION54
55150-333-01CARBOPLATIN1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-333CARBOPLATIN INJECTION, SOLUTION [EUGIA US LLC]4Current NDC, Legacy NDC, 2 package rows20250130_f5fe9a20-47a5-45b9-ab06-c6158d9b6aca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSNf5fe9a20-47a5-45b9-ab06-c6158d9b6aca4
597195carboplatin 10 MG/ML Injectable SolutionSCDf5fe9a20-47a5-45b9-ab06-c6158d9b6aca4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-333-01551500333011 VIAL, MULTI-DOSE in 1 CARTON (55150-333-01) / 5 mL in 1 VIAL, MULTI-DOSE2016-09-290000-00-00NoNoCurrent