imlygic

Generic: talimogene laherparepvec

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name imlygic
Generic Name talimogene laherparepvec
Labeler amgen inc
Dosage Form INJECTION, SUSPENSION
Routes
INTRALESIONAL
Active Ingredients

talimogene laherparepvec 1000000 [PFU]/mL

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-078
Product ID 55513-078_4d1843a8-7a83-4062-ba8c-4f97e2f1427b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125518
Listing Expiration 2026-12-31
Marketing Start 2015-11-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513078
Hyphenated Format 55513-078

Supplemental Identifiers

RxCUI
1721278 1721283 1721287 1721289
UPC
0355513079013 0355513078016
UNII
07730V90L6

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imlygic (source: ndc)
Generic Name talimogene laherparepvec (source: ndc)
Application Number BLA125518 (source: ndc)
Routes
INTRALESIONAL
source: ndc

Resolved Composition

Strengths
  • 1000000 [PFU]/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (55513-078-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

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

Ingredients (1)

talimogene laherparepvec (1000000 [PFU]/mL)

Linked Drug Pages (1)

Imlygic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRALESIONAL"], "spl_id": "4d1843a8-7a83-4062-ba8c-4f97e2f1427b", "openfda": {"upc": ["0355513079013", "0355513078016"], "unii": ["07730V90L6"], "rxcui": ["1721278", "1721283", "1721287", "1721289"], "spl_set_id": ["64ffb680-ea8c-42fc-9649-9e8c0eb77ddb"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (55513-078-01)  / 1 mL in 1 VIAL", "package_ndc": "55513-078-01", "marketing_start_date": "20151102"}], "brand_name": "Imlygic", "product_id": "55513-078_4d1843a8-7a83-4062-ba8c-4f97e2f1427b", "dosage_form": "INJECTION, SUSPENSION", "product_ndc": "55513-078", "generic_name": "talimogene laherparepvec", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imlygic", "active_ingredients": [{"name": "TALIMOGENE LAHERPAREPVEC", "strength": "1000000 [PFU]/mL"}], "application_number": "BLA125518", "marketing_category": "BLA", "marketing_start_date": "20151102", "listing_expiration_date": "20261231"}