NDC 67457-781

Docetaxel

Docetaxel

Docetaxel is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Docetaxel.

Product ID67457-781_a6417655-9448-4886-ba03-f57f36bcbd14
NDC67457-781
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel
Generic NameDocetaxel
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA208137
Labeler NameMylan Institutional LLC
Substance NameDOCETAXEL
Active Ingredient Strength20 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-781-08

1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) > 8 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-781-08 [67457078108]

Docetaxel INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA208137
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-18

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL20 mg/mL

Pharmacological Class

  • Microtubule Inhibition [PE]
  • Microtubule Inhibitor [EPC]

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

NDCBrand NameGeneric Name
0143-9204DocetaxelDocetaxel
0143-9205DocetaxelDocetaxel
0409-0016DocetaxelDOCETAXEL ANHYDROUS
0409-0201DocetaxelDOCETAXEL ANHYDROUS
0409-0365DocetaxelDOCETAXEL
0409-0366DocetaxelDOCETAXEL
0409-0367DocetaxelDOCETAXEL
0409-0368DocetaxelDOCETAXEL
0409-1732DocetaxelDOCETAXEL ANHYDROUS
0409-2026DocetaxelDOCETAXEL ANHYDROUS
0409-4235DocetaxelDOCETAXEL
70121-1222DocetaxelDocetaxel
70121-1223DocetaxelDocetaxel
70121-1221DocetaxelDocetaxel
0955-1022DocetaxelDocetaxel
0955-1020DocetaxelDocetaxel
0955-1021DocetaxelDocetaxel
16729-267DocetaxelDocetaxel
16729-231DocetaxelDocetaxel
25021-245DocetaxelDocetaxel
39822-2200DocetaxelDocetaxel
39822-2120DocetaxelDocetaxel
39822-2180DocetaxelDocetaxel
43066-001DocetaxelDocetaxel
43066-006DocetaxelDocetaxel
43066-010DocetaxelDocetaxel
43598-610DocetaxelDocetaxel
43598-258DocetaxelDocetaxel
43598-259DocetaxelDocetaxel
43598-611DocetaxelDocetaxel
45963-790DocetaxelDocetaxel
45963-734DocetaxelDocetaxel
45963-765DocetaxelDocetaxel
50742-428DOCETAXELDOCETAXEL
50742-463DOCETAXELDOCETAXEL
50742-431DOCETAXELDOCETAXEL
57884-3043DocetaxelDocetaxel
57884-3021DocetaxelDocetaxel
57884-3042DocetaxelDocetaxel
57884-3041DocetaxelDocetaxel
63739-932DocetaxelDocetaxel
63739-971DocetaxelDocetaxel
66758-950DocetaxelDocetaxel
66758-050DocetaxelDocetaxel
67457-531DocetaxelDocetaxel
67457-533DocetaxelDocetaxel
67457-532DocetaxelDocetaxel
67457-781DocetaxelDocetaxel
0075-8003TAXOTEREDocetaxel
0075-8004TAXOTEREDocetaxel

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.