NDC 70121-1631

TEPADINA

Thiotepa

TEPADINA is a Intracavitary; Intravenous; Intravesical Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Thiotepa.

Product ID70121-1631_03a98c85-6708-42db-a064-9f8e3430392b
NDC70121-1631
Product TypeHuman Prescription Drug
Proprietary NameTEPADINA
Generic NameThiotepa
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Marketing Start Date2017-08-15
Marketing CategoryNDA / NDA
Application NumberNDA208264
Labeler NameAmneal Pharmaceuticals LLC
Substance NameTHIOTEPA
Active Ingredient Strength100 mg/1
Pharm ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70121-1631-1

1 VIAL, GLASS in 1 BOX (70121-1631-1) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Marketing Start Date2017-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70121-1631-1 [70121163101]

TEPADINA INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA208264
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-15

Drug Details

Active Ingredients

IngredientStrength
THIOTEPA100 mg/1

OpenFDA Data

SPL SET ID:559e353c-2dc0-16ba-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1919209
  • 1660004
  • 1919211
  • 1660009
  • UPC Code
  • 0370121163015
  • 0370121163114
  • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]

    NDC Crossover Matching brand name "TEPADINA" or generic name "Thiotepa"

    NDCBrand NameGeneric Name
    53964-001TEPADINATHIOTEPA
    53964-002TEPADINATHIOTEPA
    70121-1630TEPADINATHIOTEPA
    70121-1631TEPADINATHIOTEPA
    0143-9309ThiotepaThiotepa
    0143-9565ThiotepaThiotepa
    25021-246ThiotepaThiotepa
    43598-171ThiotepaThiotepa
    43598-650ThiotepaThiotepa
    54879-014ThiotepaThiotepa
    65219-029ThiotepaThiotepa
    68083-446ThiotepaThiotepa
    68083-503ThiotepaThiotepa
    69539-123ThiotepaThiotepa
    69539-124ThiotepaThiotepa
    70860-220Thiotepathiotepa
    72205-045ThiotepaThiotepa
    72205-046ThiotepaThiotepa

    Trademark Results [TEPADINA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TEPADINA
    TEPADINA
    79036539 3402101 Live/Registered
    ADIENNE SRL SU
    2007-03-08

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