Docetaxel

Product NDC
47335-939
11-digit product format
473350939
Labeler code
47335
Product ID
47335-939_9a0d7b91-4324-4e19-9cd8-eb19266e771a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA022534
Marketing category
NDA
Marketing start
2020-11-26
Substance
DOCETAXEL ANHYDROUS
Active strength
160 mg/8mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
699121PHCADOCETAXEL ANHYDROUS114977-28-5DOCETAXEL ANHYDROUS
15H5577CQDDOCETAXEL148408-66-6Docetaxel

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
47335-939-40473350939401 VIAL, GLASS in 1 CARTON (47335-939-40) / 8 mL in 1 VIAL, GLASS2020-11-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DocetaxelSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2021-02-04Human Prescription Drug Label6