kebilidi

Generic: eladocagene exuparvovec-tneq

Labeler: ptc therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kebilidi
Generic Name eladocagene exuparvovec-tneq
Labeler ptc therapeutics, inc.
Dosage Form SUSPENSION
Routes
INTRACEREBRAL
Active Ingredients

eladocagene exuparvovec 560000000000 {GC}/mL

Manufacturer
PTC Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 52856-601
Product ID 52856-601_82f12b65-d2a0-450a-9f11-49ce8aad2e27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125722
Listing Expiration 2027-12-31
Marketing Start 2024-11-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52856601
Hyphenated Format 52856-601

Supplemental Identifiers

RxCUI
2698771 2698778
UPC
0352856601017
UNII
S51J6N56M7

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 kebilidi (source: ndc)
Generic Name eladocagene exuparvovec-tneq (source: ndc)
Application Number BLA125722 (source: ndc)
Routes
INTRACEREBRAL
source: ndc

Resolved Composition

Strengths
  • 560000000000 {GC}/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11)
source: ndc

Packages (1)

52856-601-01 1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11)

Ingredients (1)

eladocagene exuparvovec (560000000000 {GC}/mL)

Linked Drug Pages (1)

KEBILIDI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACEREBRAL"], "spl_id": "82f12b65-d2a0-450a-9f11-49ce8aad2e27", "openfda": {"upc": ["0352856601017"], "unii": ["S51J6N56M7"], "rxcui": ["2698771", "2698778"], "spl_set_id": ["9d6a6401-c6b5-4f29-af11-67707d249482"], "manufacturer_name": ["PTC Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (52856-601-01)  / .5 mL in 1 VIAL, GLASS (52856-601-11)", "package_ndc": "52856-601-01", "marketing_start_date": "20241113"}], "brand_name": "KEBILIDI", "product_id": "52856-601_82f12b65-d2a0-450a-9f11-49ce8aad2e27", "dosage_form": "SUSPENSION", "product_ndc": "52856-601", "generic_name": "eladocagene exuparvovec-tneq", "labeler_name": "PTC Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KEBILIDI", "active_ingredients": [{"name": "ELADOCAGENE EXUPARVOVEC", "strength": "560000000000 {GC}/mL"}], "application_number": "BLA125722", "marketing_category": "BLA", "marketing_start_date": "20241113", "listing_expiration_date": "20271231"}