Carboplatin

Product NDC
57277-105
11-digit product format
572770105
Labeler code
57277
Product ID
57277-105_09c0db7d-1392-4d2b-9fca-07e8272df7de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboplatin Injection
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Sanja Pharmaceuticals Company
Application
ANDA205487
Marketing category
ANDA
Marketing start
2016-09-29
Marketing end
0000-00-00
Substance
CARBOPLATIN
Active strength
50 mg/5mL
Pharmacologic classes
Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
57277-105-052020-01-31C16284748780-19d75b9cf-f398-f424-e053-dadaa90a57ceCARBOPLATIN- carboplatin injection, solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57277-105-05Carboplatin1 in 1 CARTONSOLUTION12
57277-105-05Carboplatin5 mL in 1 VIAL, MULTI-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57277-105CARBOPLATIN (CARBOPLATIN INJECTION) SOLUTION [SANJA PHARMACEUTICALS COMPANY]2Legacy NDC, 2 package rows20160929_f4baa639-287b-4d97-923f-ce5c6add531c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSNf4baa639-287b-4d97-923f-ce5c6add531c2
597195carboplatin 10 MG/ML Injectable SolutionSCDf4baa639-287b-4d97-923f-ce5c6add531c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57277-105-05572770105051 in 1 CARTONHistorical