NDC 69539-123

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 ID: 69539-123_1c6a2caa-abd7-4e8b-830f-e4fcf73e949a
• NDC: 69539-123
• Product Type: Human Prescription Drug
• Proprietary Name: Thiotepa
• Generic Name: Thiotepa
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
• Marketing Start Date: 2020-03-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA213049
• Labeler Name: MSN LABORATORIES PRIVATE LIMITED
• Substance Name: THIOTEPA
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69539-123-01

1 VIAL, GLASS in 1 BOX (69539-123-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

• Marketing Start Date: 2020-03-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69539-123-01 [69539012301]

Thiotepa INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA213049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-04

Drug Details

Active Ingredients

Ingredient	Strength
THIOTEPA	15 mg/1

OpenFDA Data

• SPL SET ID: 6cb2e63c-1180-4201-b596-233d1b1a5dc8
• Manufacturer:
  • MSN LABORATORIES PRIVATE LIMITED
• UNII:
  • 905Z5W3GKH
• 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"

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