CARBOPLATIN

Product NDC
60505-6282
11-digit product format
605056282
Labeler code
60505
Product ID
60505-6282_0e68e276-b0df-4f03-e063-6394a90a22b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPLATIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA077861
Marketing category
ANDA
Marketing start
2007-01-18
Substance
CARBOPLATIN
Active strength
10 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
CARBOPLATIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOPLATIN10 mg/mL

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
60505-6282-1CARBOPLATIN5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
60505-6282-1CARBOPLATIN1 in 1 CARTONINJECTION, SOLUTION12
60505-6282-3CARBOPLATIN1 in 1 CARTONINJECTION, SOLUTION12
60505-6282-3CARBOPLATIN15 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION152
60505-6282-6CARBOPLATIN45 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION452
60505-6282-6CARBOPLATIN1 in 1 CARTONINJECTION, SOLUTION12
60505-6282-7CARBOPLATIN1 in 1 CARTONINJECTION, SOLUTION12
60505-6282-7CARBOPLATIN60 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6282-1ML - Milliliter60505-62829790df0b-25ca-4d59-8d12-ca8f004c20b612024-02-14
60505-6282-3ML - Milliliter60505-628227a33526-ef00-4799-abf3-27a81d20378112024-02-14
60505-6282-6ML - Milliliter60505-62820da60415-65ff-4821-a771-3592dcd5af7612024-02-14
60505-6282-7ML - Milliliter60505-6282025f07aa-5eb3-4364-8c8b-ce12a6ad324112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6282CARBOPLATIN INJECTION, SOLUTION [APOTEX CORP.]2Current NDC, 8 package rows20240108_1c275825-0275-4c73-b650-e4c1519f13b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSN1c275825-0275-4c73-b650-e4c1519f13b82
597195carboplatin 10 MG/ML Injectable SolutionSCD1c275825-0275-4c73-b650-e4c1519f13b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6282-1605056282011 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-1) / 5 mL in 1 VIAL, MULTI-DOSE2024-01-10NoNoHistorical
60505-6282-3605056282031 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-3) / 15 mL in 1 VIAL, MULTI-DOSE2024-01-10NoNoHistorical
60505-6282-6605056282061 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-6) / 45 mL in 1 VIAL, MULTI-DOSE2024-01-10NoNoHistorical
60505-6282-7605056282071 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-7) / 60 mL in 1 VIAL, MULTI-DOSE2024-01-10NoNoHistorical