FDA.reportPublic FDA data

Carboplatin

Product NDC
61703-339
11-digit product format
617030339
Labeler code
61703
Product ID
61703-339_0ddf4411-7138-412a-908a-fadf22bdfb79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA076517
Marketing category
ANDA
Marketing start
2004-10-14
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
61703-339-18Carboplatin1 in 1 CARTONINJECTION, SOLUTION116
61703-339-18Carboplatin5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION516
61703-339-22Carboplatin1 in 1 CARTONINJECTION, SOLUTION116
61703-339-22Carboplatin15 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1516
61703-339-50Carboplatin1 in 1 CARTONINJECTION, SOLUTION116
61703-339-50Carboplatin45 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION4516
61703-339-56Carboplatin60 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION6016
61703-339-56Carboplatin1 in 1 CARTONINJECTION, SOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-339-18ML - Milliliter61703-339b134fcf2-2f5f-498c-9dda-6c6401a1811e12012-07-24
61703-339-22ML - Milliliter61703-339ec151454-d7b6-4d4b-8297-d06592c612b612012-07-24
61703-339-50ML - Milliliter61703-339ac44c478-749d-4afb-a862-3dbd7ce2a3d912012-07-24
61703-339-56ML - Milliliter61703-339988bbeec-60ab-4c5d-856c-92c88493270712012-07-24
61703-339-61ML - Milliliter61703-3393ddc13ee-5618-4f38-a139-4566baf3dfdf12012-07-24
61703-339-62ML - Milliliter61703-339a9b24672-183f-47c7-bf25-8bb4ef46a71212012-07-24
61703-339-63ML - Milliliter61703-339243e9828-d283-411d-a79a-72542c36df5c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarboplatinACTIVE INGREDIENTBG3F62OND5CARBOPLATIN INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]5
CarboplatinACTIVE MOIETYBG3F62OND5CARBOPLATIN INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RCARBOPLATIN INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-339CARBOPLATIN INJECTION, SOLUTION [HOSPIRA, INC.]16Current NDC, Legacy NDC, 8 package rows20240622_c3ae9880-44bb-4f4e-93d8-8a5e21708a30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSNc3ae9880-44bb-4f4e-93d8-8a5e21708a3016
597195carboplatin 10 MG/ML Injectable SolutionSCDc3ae9880-44bb-4f4e-93d8-8a5e21708a3016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-339-18617030339181 VIAL, MULTI-DOSE in 1 CARTON (61703-339-18) / 5 mL in 1 VIAL, MULTI-DOSE2004-10-140000-00-00NoNoCurrent
61703-339-22617030339221 VIAL, MULTI-DOSE in 1 CARTON (61703-339-22) / 15 mL in 1 VIAL, MULTI-DOSE2004-10-140000-00-00NoNoCurrent
61703-339-50617030339501 VIAL, MULTI-DOSE in 1 CARTON (61703-339-50) / 45 mL in 1 VIAL, MULTI-DOSE2004-10-140000-00-00NoNoCurrent
61703-339-56617030339561 VIAL, MULTI-DOSE in 1 CARTON (61703-339-56) / 60 mL in 1 VIAL, MULTI-DOSE2004-11-230000-00-00NoNoCurrent