Carboplatin

Product NDC
63323-172
11-digit product format
633230172
Labeler code
63323
Product ID
63323-172_3a1dd588-13b0-4d58-8d46-3a25a4fc6b40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPLATIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA077266
Marketing category
ANDA
Marketing start
2009-12-11
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
63323-172-60Carboplatin60 mL in 1 VIALINJECTION, SOLUTION604
63323-172-60Carboplatin1 in 1 BOXINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-172-05ML - Milliliter63323-172cb987630-190a-4676-8d26-6605490fada012012-07-24
63323-172-15ML - Milliliter63323-172426aa91e-aa4f-4c51-a1ef-0403c1fc169112012-07-24
63323-172-45ML - Milliliter63323-1728f9c9de2-6c81-432f-8c19-cf238283603912012-07-24
63323-172-60ML - Milliliter63323-172b597082a-b6f1-4f3b-b3aa-053c0a51679412017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-172CARBOPLATIN (CARBOPLATIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20211110_b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSNb4fa7aac-c9d2-4af4-a281-3e6cfc502ff64
597195carboplatin 10 MG/ML Injectable SolutionSCDb4fa7aac-c9d2-4af4-a281-3e6cfc502ff64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-172-60633230172601 VIAL in 1 BOX (63323-172-60) / 60 mL in 1 VIAL1 vial2009-12-110000-00-00NoNoCurrent