DOCETAXEL

Product NDC
50742-428
11-digit product format
507420428
Labeler code
50742
Product ID
50742-428_022dc11f-b37d-4885-bf1a-99ba78f93114
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-428-02ML - Milliliter50742-4288990dcb8-6b5f-4b88-88ac-e17fcddcd6b812018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-428DOCETAXEL (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
50742-428-02507420428021 VIAL, SINGLE-DOSE in 1 CARTON (50742-428-02) > 2 mL in 1 VIAL, SINGLE-DOSE2017-09-070000-00-00NoNoCurrent