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 ID: 25021-246_0f528533-434c-4ce1-8596-a69319aee583
• NDC: 25021-246
• Product Type: Human Prescription Drug
• Proprietary Name: Thiotepa
• Generic Name: Thiotepa
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
• Marketing Start Date: 2018-06-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209150
• Labeler Name: Sagent Pharmaceuticals
• Substance Name: THIOTEPA
• Active Ingredient Strength: 15 mg/1.5mL
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 25021-246-02

1 VIAL in 1 CARTON (25021-246-02) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2018-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25021-246-02 [25021024602]

Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209150
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-15

Drug Details

Active Ingredients

Ingredient	Strength
THIOTEPA	15 mg/1.5mL

OpenFDA Data

• SPL SET ID: 448c29f1-6d9c-4f8e-8a69-9b85e973e728
• Manufacturer:
  • Sagent Pharmaceuticals
• UNII:
  • 905Z5W3GKH
• 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"

NDC	Brand Name	Generic Name
0143-9309	Thiotepa	Thiotepa
0143-9565	Thiotepa	Thiotepa
25021-246	Thiotepa	Thiotepa
43598-171	Thiotepa	Thiotepa
43598-650	Thiotepa	Thiotepa
54879-014	Thiotepa	Thiotepa
65219-029	Thiotepa	Thiotepa
68083-446	Thiotepa	Thiotepa
68083-503	Thiotepa	Thiotepa
69539-123	Thiotepa	Thiotepa
69539-124	Thiotepa	Thiotepa
70860-220	Thiotepa	thiotepa
72205-045	Thiotepa	Thiotepa
72205-046	Thiotepa	Thiotepa
53964-001	TEPADINA	THIOTEPA
53964-002	TEPADINA	THIOTEPA
70121-1630	TEPADINA	THIOTEPA
70121-1631	TEPADINA	THIOTEPA