NDC 68083-503

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 Gland Pharma Limited. The primary component is Thiotepa.

• Product ID: 68083-503_283f8e9e-6f72-4e0b-9459-e7d4430ad0ee
• NDC: 68083-503
• 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: 2022-01-03
• Marketing Category: ANDA /
• Application Number: ANDA214222
• Labeler Name: Gland Pharma Limited
• Substance Name: THIOTEPA
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68083-503-01

1 VIAL in 1 CARTON (68083-503-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2022-01-03
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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