Docetaxel

Product NDC
46708-678
11-digit product format
467080678
Labeler code
46708
Product ID
46708-678_682a0b1a-3277-4718-a94e-9645633062bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215744
Marketing category
ANDA
Marketing start
2023-02-28
Substance
DOCETAXEL ANHYDROUS
Active strength
10 mg/mL
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
46708-678-02467080678021 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE2023-02-28NoNoHistorical
46708-678-08467080678081 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08) / 8 mL in 1 VIAL, MULTI-DOSE2023-02-28NoNoHistorical
46708-678-16467080678161 VIAL, MULTI-DOSE in 1 CARTON (46708-678-16) / 16 mL in 1 VIAL, MULTI-DOSE2023-02-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DocetaxelAlembic Pharmaceuticals Limited2023-04-27Human Prescription Drug Label1