CISplatin

Product NDC
60505-6279
11-digit product format
605056279
Labeler code
60505
Product ID
60505-6279_0e147fbc-5660-4d80-b834-f069e8487f59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CISplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA218868
Marketing category
ANDA
Marketing start
2024-09-13
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
60505-6279-0CISplatin1 in 1 CARTONINJECTION, SOLUTION15
60505-6279-0CISplatin50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6279-0ML - Milliliter60505-627927156541-e5d3-4b6f-bb46-7ad563169ca812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6279CISPLATIN INJECTION, SOLUTION [APOTEX CORP.]5Current NDC, 2 package rows20240920_8d170f6f-37d7-41ce-aae2-33307a6ef3ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309311CISplatin 1 MG/ML Injectable SolutionPSN8d170f6f-37d7-41ce-aae2-33307a6ef3ae5
309311cisplatin 1 MG/ML Injectable SolutionSCD8d170f6f-37d7-41ce-aae2-33307a6ef3ae5
309311cisplatin 100 MG per 100 ML Injectable SolutionSY8d170f6f-37d7-41ce-aae2-33307a6ef3ae5
309311cisplatin 50 MG per 50 ML Injectable SolutionSY8d170f6f-37d7-41ce-aae2-33307a6ef3ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6279-0605056279001 VIAL, MULTI-DOSE in 1 CARTON (60505-6279-0) / 50 mL in 1 VIAL, MULTI-DOSE2024-09-13NoNoHistorical