FDA.reportPublic FDA data

Cisplatin

Product NDC
25021-253
11-digit product format
250210253
Labeler code
25021
Product ID
25021-253_bf489cd3-17a3-4398-ba7e-2cb9e87b9c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207323
Marketing category
ANDA
Marketing start
2023-07-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-253-50Cisplatin1 in 1 CARTONINJECTION, SOLUTION12
25021-253-50Cisplatin50 mL in 1 VIALINJECTION, SOLUTION502
25021-253-51Cisplatin1 in 1 CARTONINJECTION, SOLUTION12
25021-253-51Cisplatin100 mL in 1 VIALINJECTION, SOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-253-50ML - Milliliter25021-2536b7700d8-988c-45f7-b28b-91c24acd5bd212023-08-08
25021-253-51ML - Milliliter25021-253df51474b-22bb-433f-993d-039d5cdd8d0712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-253CISPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2Current NDC, 4 package rows20240229_00396546-6a80-4b9f-a5f8-c22c1d1bb173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309311CISplatin 1 MG/ML Injectable SolutionPSN00396546-6a80-4b9f-a5f8-c22c1d1bb1732
309311cisplatin 1 MG/ML Injectable SolutionSCD00396546-6a80-4b9f-a5f8-c22c1d1bb1732
309311cisplatin 100 MG per 100 ML Injectable SolutionSY00396546-6a80-4b9f-a5f8-c22c1d1bb1732
309311cisplatin 50 MG per 50 ML Injectable SolutionSY00396546-6a80-4b9f-a5f8-c22c1d1bb1732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-253-50250210253501 VIAL in 1 CARTON (25021-253-50) / 50 mL in 1 VIAL1 vial2023-07-01NoNoHistorical
25021-253-51250210253511 VIAL in 1 CARTON (25021-253-51) / 100 mL in 1 VIAL1 vial2023-07-01NoNoHistorical