NDC 25021-246

Thiotepa

Thiotepa

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

Product ID25021-246_0f528533-434c-4ce1-8596-a69319aee583
NDC25021-246
Product TypeHuman Prescription Drug
Proprietary NameThiotepa
Generic NameThiotepa
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Marketing Start Date2018-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA209150
Labeler NameSagent Pharmaceuticals
Substance NameTHIOTEPA
Active Ingredient Strength15 mg/1.5mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 25021-246-02

1 VIAL in 1 CARTON (25021-246-02) > 1.5 mL in 1 VIAL
Marketing Start Date2018-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-246-02 [25021024602]

Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA209150
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-15

Drug Details

Active Ingredients

IngredientStrength
THIOTEPA15 mg/1.5mL

OpenFDA Data

SPL SET ID:448c29f1-6d9c-4f8e-8a69-9b85e973e728
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1660009
  • Pharmacological Class

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