NDC 72485-215

Docetaxel

Docetaxel

Docetaxel is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is Docetaxel.

Product ID72485-215_8c30c9d6-97ac-42b0-a5dc-97f56e94c3bb
NDC72485-215
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel
Generic NameDocetaxel
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA210327
Labeler NameArmas Pharmaceuticals Inc.
Substance NameDOCETAXEL
Active Ingredient Strength80 mg/4mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72485-215-04

1 VIAL, SINGLE-USE in 1 CARTON (72485-215-04) > 4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2020-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-215-04 [72485021504]

Docetaxel INJECTION
Marketing CategoryANDA
Application NumberANDA210327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-15

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL80 mg/4mL

OpenFDA Data

SPL SET ID:7c1927a7-82ad-44ed-831e-5d4a88ac18f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860485
  • 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

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