NDC 16729-098

Paclitaxel

Paclitaxel

Paclitaxel is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is Paclitaxel.

Product ID16729-098_c12ad367-5f50-5668-e053-2995a90a04e2
NDC16729-098
Product TypeHuman Prescription Drug
Proprietary NamePaclitaxel
Generic NamePaclitaxel
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-06-15
Marketing CategoryANDA /
Application NumberANDA205720
Labeler NameAccord Healthcare, Inc.
Substance NamePACLITAXEL
Active Ingredient Strength6 mg/mL
Pharm ClassesMicrotubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 16729-098-05

1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-05) > 16.7 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2022-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-098-11 [16729009811]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205720
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17
Marketing End Date2018-08-17

NDC 16729-098-05 [16729009805]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205720
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17
Marketing End Date2018-08-17

NDC 16729-098-31 [16729009831]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205720
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17
Marketing End Date2018-08-17

Drug Details

NDC Crossover Matching brand name "Paclitaxel" or generic name "Paclitaxel"

NDCBrand NameGeneric Name
0703-3213PaclitaxelPaclitaxel
0703-3216PaclitaxelPaclitaxel
0703-3217PaclitaxelPaclitaxel
0703-3218PaclitaxelPaclitaxel
0703-4764PaclitaxelPaclitaxel
0703-4766PaclitaxelPaclitaxel
0703-4767PaclitaxelPaclitaxel
0703-4768PaclitaxelPaclitaxel
16714-137PaclitaxelPaclitaxel
16729-098PaclitaxelPACLITAXEL
44567-504PaclitaxelPaclitaxel
44567-505PaclitaxelPaclitaxel
44567-506PaclitaxelPaclitaxel
45963-613PaclitaxelPaclitaxel
47781-593Paclitaxelpaclitaxel
70860-200PaclitaxelPaclitaxel
47781-595PaclitaxelPaclitaxel
47781-594PaclitaxelPaclitaxel
51991-938PaclitaxelPaclitaxel
51991-937PaclitaxelPaclitaxel
51991-936PaclitaxelPaclitaxel
61703-342PaclitaxelPaclitaxel
63323-763PaclitaxelPaclitaxel
67457-449PaclitaxelPaclitaxel
67457-434PaclitaxelPaclitaxel
67457-471PaclitaxelPaclitaxel
70860-215PaclitaxelPaclitaxel
24979-710Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)Paclitaxel

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.