NDC 68083-202

Temsirolimus

Temsirolimus Injection

Temsirolimus is a Kit in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is .

• Product ID: 68083-202_45d15ea9-1902-49de-9c84-6ef8ee60bf14
• NDC: 68083-202
• Product Type: Human Prescription Drug
• Proprietary Name: Temsirolimus
• Generic Name: Temsirolimus Injection
• Dosage Form: Kit
• Marketing Start Date: 2019-08-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207383
• Labeler Name: Gland Pharma Limited
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68083-202-01

1 KIT in 1 CARTON (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)

• Marketing Start Date: 2019-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-202-01 [68083020201]

Temsirolimus KIT

• Marketing Category: ANDA
• Application Number: ANDA207383
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-26

Drug Details

OpenFDA Data

• SPL SET ID: d7ee3165-175d-4439-8740-fbfed18aaf0e
• Manufacturer:
  • Gland Pharma Limited
• RxNorm Concept Unique ID - RxCUI:
  • 722289

NDC Crossover Matching brand name "Temsirolimus" or generic name "Temsirolimus Injection"

NDC	Brand Name	Generic Name
16729-223	Temsirolimus	temsirolimus
65219-200	Temsirolimus	Temsirolimus
68083-202	Temsirolimus	Temsirolimus Injection
72611-785	Temsirolimus	Temsirolimus Injection
0008-1179	Torisel	temsirolimus