NDC 55513-078

Imlygic

Talimogene Laherparepvec

Imlygic is a Intralesional Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Talimogene Laherparepvec.

• Product ID: 55513-078_0ff7fc11-9247-4b5b-a0bc-ca1d3f29eec2
• NDC: 55513-078
• Product Type: Human Prescription Drug
• Proprietary Name: Imlygic
• Generic Name: Talimogene Laherparepvec
• Dosage Form: Injection, Suspension
• Route of Administration: INTRALESIONAL
• Marketing Start Date: 2015-11-02
• Marketing Category: BLA / BLA
• Application Number: BLA125518
• Labeler Name: Amgen Inc
• Substance Name: TALIMOGENE LAHERPAREPVEC
• Active Ingredient Strength: 1000000 [PFU]/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55513-078-01

1 VIAL in 1 CARTON (55513-078-01) > 1 mL in 1 VIAL

• Marketing Start Date: 2015-11-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-078-01 [55513007801]

Imlygic INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125518
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-02

Drug Details

Active Ingredients

Ingredient	Strength
TALIMOGENE LAHERPAREPVEC	1000000 [PFU]/mL

OpenFDA Data

• SPL SET ID: 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
• Manufacturer:
  • Amgen Inc
• UNII:
  • 07730V90L6
• RxNorm Concept Unique ID - RxCUI:
  • 1721289
  • 1721287
  • 1721278
  • 1721283
• UPC Code:
  • 0355513078016
  • 0355513079013

NDC Crossover Matching brand name "Imlygic" or generic name "Talimogene Laherparepvec"

NDC	Brand Name	Generic Name
55513-078	Imlygic	talimogene laherparepvec
55513-079	Imlygic	talimogene laherparepvec