Cisplatin

Product NDC
16729-288
11-digit product format
167290288
Labeler code
16729
Product ID
16729-288_2860827e-1817-2b85-e063-6394a90a127e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisplatin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
ANDA206774
Marketing category
ANDA
Marketing start
2016-12-13
Substance
CISPLATIN
Active strength
1 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
Cisplatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISPLATIN1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ20Q21Q62J
Rxcui309311

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c9c59a98-9c44-9141-5aed-28a9bfc56d6eProduct name420250220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-288-11Cisplatin50 mL in 1 VIALINJECTION506
16729-288-38Cisplatin100 mL in 1 VIALINJECTION1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-288-11ML - Milliliter16729-2881e56a1d1-4163-4be6-ac27-197ff498977012017-03-06
16729-288-38ML - Milliliter16729-288a6047f53-15e5-475a-9e06-136513f41cfc12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-288CISPLATIN INJECTION [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 2 package rows20241206_b2b029f5-0d7e-4e7f-accc-b722aec34c68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309311CISplatin 1 MG/ML Injectable SolutionPSNb2b029f5-0d7e-4e7f-accc-b722aec34c686
309311cisplatin 1 MG/ML Injectable SolutionSCDb2b029f5-0d7e-4e7f-accc-b722aec34c686
309311cisplatin 100 MG per 100 ML Injectable SolutionSYb2b029f5-0d7e-4e7f-accc-b722aec34c686
309311cisplatin 50 MG per 50 ML Injectable SolutionSYb2b029f5-0d7e-4e7f-accc-b722aec34c686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-288-111672902881150 mL in 1 VIAL (16729-288-11) 50 ml2016-12-130000-00-00NoNoCurrent
16729-288-3816729028838100 mL in 1 VIAL (16729-288-38) 100 ml2016-12-130000-00-00NoNoCurrent