NDC 0143-9309

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 West-ward Pharmaceuticals. The primary component is Thiotepa.

• Product ID: 0143-9309_2372266c-7c5b-4a01-bda4-8c32b634c73d
• NDC: 0143-9309
• 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: 2001-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075547
• Labeler Name: West-Ward Pharmaceuticals
• Substance Name: THIOTEPA
• Active Ingredient Strength: 15 mg/1.5mL
• Pharm Classes: Alkylating Acti
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0143-9309-01

1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2001-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0143-9309-01 [00143930901]

Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075547
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-06-01

Drug Details

Active Ingredients

Ingredient	Strength
THIOTEPA	15 mg/1.5mL

Pharmacological Class

• 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