NDC 69539-124

Thiotepa

Thiotepa

Thiotepa is a Intracavitary; Intravenous; Intravesical Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Thiotepa.

Product ID69539-124_1c6a2caa-abd7-4e8b-830f-e4fcf73e949a
NDC69539-124
Product TypeHuman Prescription Drug
Proprietary NameThiotepa
Generic NameThiotepa
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Marketing Start Date2020-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA213049
Labeler NameMSN LABORATORIES PRIVATE LIMITED
Substance NameTHIOTEPA
Active Ingredient Strength100 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69539-124-01

1 VIAL, GLASS in 1 BOX (69539-124-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Marketing Start Date2020-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69539-124-01 [69539012401]

Thiotepa INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA213049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-04

Drug Details

Active Ingredients

IngredientStrength
THIOTEPA100 mg/1

OpenFDA Data

SPL SET ID:6cb2e63c-1180-4201-b596-233d1b1a5dc8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1660004
  • 1660009
  • UPC Code
  • 0369539124015
  • 0369539123018
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    53964-001TEPADINATHIOTEPA
    53964-002TEPADINATHIOTEPA
    70121-1630TEPADINATHIOTEPA
    70121-1631TEPADINATHIOTEPA

    Trademark Results [Thiotepa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    THIOTEPA
    THIOTEPA
    73471323 not registered Dead/Abandoned
    AMERICAN CYANAMID COMPANY
    1984-03-21

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