sephience

Generic: sepiapterin

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

Drug Facts

Product Profile

Brand Name sephience
Generic Name sepiapterin
Labeler ptc therapeutics inc.
Dosage Form POWDER
Routes
ORAL
Active Ingredients

sepiapterin 250 mg/1

Manufacturer
PTC Therapeutics Inc.

Identifiers & Regulatory

Product NDC 52856-201
Product ID 52856-201_1058e322-6878-46c2-917d-3f65c8b36aeb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219666
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52856201
Hyphenated Format 52856-201

Supplemental Identifiers

RxCUI
2723061 2723067 2723069 2723071
UPC
0352856201033 0352856301030
UNII
CJQ26KO7HP

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 sephience (source: ndc)
Generic Name sepiapterin (source: ndc)
Application Number NDA219666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (52856-201-03) / 1 POWDER in 1 PACKET (52856-201-01)
source: ndc

Packages (1)

52856-201-03 30 PACKET in 1 CARTON (52856-201-03) / 1 POWDER in 1 PACKET (52856-201-01)

Ingredients (1)

sepiapterin (250 mg/1)

Linked Drug Pages (1)

Sephience ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1058e322-6878-46c2-917d-3f65c8b36aeb", "openfda": {"upc": ["0352856201033", "0352856301030"], "unii": ["CJQ26KO7HP"], "rxcui": ["2723061", "2723067", "2723069", "2723071"], "spl_set_id": ["32ac719c-49f0-4105-9c46-18c19583a5c2"], "manufacturer_name": ["PTC Therapeutics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (52856-201-03)  / 1 POWDER in 1 PACKET (52856-201-01)", "package_ndc": "52856-201-03", "marketing_start_date": "20250728"}], "brand_name": "Sephience", "product_id": "52856-201_1058e322-6878-46c2-917d-3f65c8b36aeb", "dosage_form": "POWDER", "product_ndc": "52856-201", "generic_name": "sepiapterin", "labeler_name": "PTC Therapeutics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sephience", "active_ingredients": [{"name": "SEPIAPTERIN", "strength": "250 mg/1"}], "application_number": "NDA219666", "marketing_category": "NDA", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}