carboplatin

Product NDC
47335-284
11-digit product format
473350284
Labeler code
47335
Product ID
47335-284_2f46de65-7dc6-4011-a9f4-228d16df72fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboplatin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077926
Marketing category
ANDA
Marketing start
2014-03-03
Marketing end
0000-00-00
Substance
CARBOPLATIN
Active strength
10 mg/mL
Pharmacologic classes
Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47335-284-402020-01-31C16284748780-19d75b9d0-bc7a-f424-e053-dadaa90a57ceCarboplatin Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-284-40carboplatin60 mL in 1 VIAL, MULTI-DOSEINJECTION603
47335-284-40carboplatin1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-284-40ML - Milliliter47335-284f5000b19-a46f-46a7-9f37-ff0b17ee5dc412014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBOPLATINACTIVE INGREDIENTBG3F62OND5CARBOPLATIN INJECTION [SUN PHARMA GLOBAL FZE]1
CARBOPLATINACTIVE MOIETYBG3F62OND5CARBOPLATIN INJECTION [SUN PHARMA GLOBAL FZE]1
WATERINACTIVE INGREDIENT059QF0KO0RCARBOPLATIN INJECTION [SUN PHARMA GLOBAL FZE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-284CARBOPLATIN INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Legacy NDC, 2 package rows20181025_2ccca2f5-518d-438c-8e62-5b1bcf2005b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSN2ccca2f5-518d-438c-8e62-5b1bcf2005b73
597195carboplatin 10 MG/ML Injectable SolutionSCD2ccca2f5-518d-438c-8e62-5b1bcf2005b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
47335-284-404733502844060 mL in 1 VIAL, MULTI-DOSE60 mlHistorical