FDA.reportPublic FDA data

Sephience

Product NDC
52856-301
11-digit product format
528560301
Labeler code
52856
Product ID
52856-301_15baff9a-9d66-4546-b209-7a570a2f16c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sepiapterin
Dosage form
POWDER
Route
ORAL
Labeler
PTC Therapeutics Inc.
Application
NDA219666
Marketing category
NDA
Marketing start
2025-07-28
Substance
SEPIAPTERIN
Active strength
1000 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sephience
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEPIAPTERIN1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCJQ26KO7HP
Rxcui2723061, 2723067, 2723069, 2723071

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52856-301-01Sephience1 in 1 PACKETPOWDER16
52856-301-03Sephience30 in 1 CARTONPOWDER306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52856-301-01EA - Each52856-3010a107ed2-1cde-4e6a-bfc7-f993d7765e4712025-09-12
52856-301-03EA - Each52856-3014eff6e5a-9d46-421d-8907-727b5ae705ff12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723067Sephience 1000 MG Oral PowderPSN32ac719c-49f0-4105-9c46-18c19583a5c26
2723071Sephience 250 MG Oral PowderPSN32ac719c-49f0-4105-9c46-18c19583a5c26
2723061sepiapterin 1000 MG Oral PowderPSN32ac719c-49f0-4105-9c46-18c19583a5c26
2723069sepiapterin 250 MG Oral PowderPSN32ac719c-49f0-4105-9c46-18c19583a5c26
2723067sepiapterin 1000 MG Oral Powder [Sephience]SBD32ac719c-49f0-4105-9c46-18c19583a5c26
2723071sepiapterin 250 MG Oral Powder [Sephience]SBD32ac719c-49f0-4105-9c46-18c19583a5c26
2723061sepiapterin 1000 MG Oral PowderSCD32ac719c-49f0-4105-9c46-18c19583a5c26
2723069sepiapterin 250 MG Oral PowderSCD32ac719c-49f0-4105-9c46-18c19583a5c26
2723067Sephience 1000 MG Oral PowderSY32ac719c-49f0-4105-9c46-18c19583a5c26
2723071Sephience 250 MG Oral PowderSY32ac719c-49f0-4105-9c46-18c19583a5c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52856-301-01528560301011 in 1 PACKETHistorical
52856-301-035285603010330 PACKET in 1 CARTON (52856-301-03) / 1 POWDER in 1 PACKET (52856-301-01) 30 packet2025-07-28NoNoCurrent