Paclitaxel

Product NDC
46708-620
11-digit product format
467080620
Labeler code
46708
Product ID
46708-620_6d04b514-c85c-4db1-919e-21dd98172791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA216874
Marketing category
ANDA
Marketing start
2022-10-20
Substance
PACLITAXEL
Active strength
6 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
P88XT4IS4DPACLITAXEL33069-62-4PACLITAXEL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-620-05467080620051 VIAL, MULTI-DOSE in 1 CARTON (46708-620-05) / 5 mL in 1 VIAL, MULTI-DOSE2022-10-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Paclitaxel Injection, USP (Patient Information Included) Rx OnlyAlembic Pharmaceuticals Limited2023-01-31Human Prescription Drug Label1