Carboplatin

Product NDC
16729-295
11-digit product format
167290295
Labeler code
16729
Product ID
16729-295_35cf6068-f31a-211b-e063-6294a90a6b53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboplatin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA206775
Marketing category
ANDA
Marketing start
2017-09-19
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
16729-295-12Carboplatin60 mL in 1 VIAL, MULTI-DOSEINJECTION608
16729-295-12Carboplatin1 in 1 CARTONINJECTION18
16729-295-31Carboplatin1 in 1 CARTONINJECTION18
16729-295-31Carboplatin5 mL in 1 VIAL, MULTI-DOSEINJECTION58
16729-295-33Carboplatin15 mL in 1 VIAL, MULTI-DOSEINJECTION158
16729-295-33Carboplatin1 in 1 CARTONINJECTION18
16729-295-34Carboplatin1 in 1 CARTONINJECTION18
16729-295-34Carboplatin45 mL in 1 VIAL, MULTI-DOSEINJECTION458
16729-295-38Carboplatin1 in 1 CARTONINJECTION18
16729-295-38Carboplatin100 mL in 1 VIAL, MULTI-DOSEINJECTION1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-295-12ML - Milliliter16729-295645e905e-b086-4208-8cd7-e5251ff1f4d812017-10-13
16729-295-31ML - Milliliter16729-295811902ac-4b72-447e-98a6-5131b4257ba012017-10-13
16729-295-33ML - Milliliter16729-295dc2894c9-ec13-4931-9fde-016a13e942de12017-10-13
16729-295-34ML - Milliliter16729-295beb43d1f-26ce-4793-9130-c8b0ca9e1f3512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-295CARBOPLATIN INJECTION [ACCORD HEALTHCARE, INC.]8Current NDC, Legacy NDC, 10 package rows20250524_48aa7ef3-9f44-2a08-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597195CARBOplatin 10 MG/ML Injectable SolutionPSN48aa7ef3-9f44-2a08-e054-00144ff88e888
597195carboplatin 10 MG/ML Injectable SolutionSCD48aa7ef3-9f44-2a08-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-295-12167290295121 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12) / 60 mL in 1 VIAL, MULTI-DOSE2017-10-030000-00-00NoNoCurrent
16729-295-31167290295311 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31) / 5 mL in 1 VIAL, MULTI-DOSE2017-09-190000-00-00NoNoCurrent
16729-295-33167290295331 VIAL, MULTI-DOSE in 1 CARTON (16729-295-33) / 15 mL in 1 VIAL, MULTI-DOSE2017-09-190000-00-00NoNoCurrent
16729-295-34167290295341 VIAL, MULTI-DOSE in 1 CARTON (16729-295-34) / 45 mL in 1 VIAL, MULTI-DOSE2017-09-190000-00-00NoNoCurrent
16729-295-38167290295381 in 1 CARTONHistorical