DOCETAXEL

Product NDC
50742-431
11-digit product format
507420431
Labeler code
50742
Product ID
50742-431_4e07912c-8e9d-41c3-9408-d2e5dd9d5e7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOCETAXEL ANHYDROUS
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA207563
Marketing category
ANDA
Marketing start
2017-09-07
Marketing end
0000-00-00
Substance
DOCETAXEL ANHYDROUS
Active strength
10 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-431-08ML - Milliliter50742-431234d7f42-102c-44b9-9778-ace1973df33112018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-431DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION, SOLUTION [INGENUS PHARMACEUTICALS, LLC]13Legacy NDC20240201_b17679e8-88c8-4b8d-bfae-246fab6eead9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-431-08507420431081 VIAL, MULTI-DOSE in 1 CARTON (50742-431-08) > 8 mL in 1 VIAL, MULTI-DOSE2017-09-070000-00-00NoNoCurrent