Sephience
- Product NDC
- 52856-201
- 11-digit product format
- 528560201
- Labeler code
- 52856
- Product ID
- 52856-201_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
- 250 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 |
|---|---|
| SEPIAPTERIN | 250 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | CJQ26KO7HP |
| Rxcui | 2723061, 2723067, 2723069, 2723071 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52856-201-01 | Sephience | 1 in 1 PACKET | POWDER | 1 | 6 | |
| 52856-201-03 | Sephience | 30 in 1 CARTON | POWDER | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52856-201-01 | EA - Each | 52856-201 | 0da4d1af-e09f-493c-8a88-208c179aaea9 | 1 | 2025-09-12 |
| 52856-201-03 | EA - Each | 52856-201 | 015a178a-196f-47ff-82d0-577663f1e2c2 | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2723067 | Sephience 1000 MG Oral Powder | PSN | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723071 | Sephience 250 MG Oral Powder | PSN | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723061 | sepiapterin 1000 MG Oral Powder | PSN | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723069 | sepiapterin 250 MG Oral Powder | PSN | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723067 | sepiapterin 1000 MG Oral Powder [Sephience] | SBD | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723071 | sepiapterin 250 MG Oral Powder [Sephience] | SBD | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723061 | sepiapterin 1000 MG Oral Powder | SCD | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723069 | sepiapterin 250 MG Oral Powder | SCD | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723067 | Sephience 1000 MG Oral Powder | SY | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
| 2723071 | Sephience 250 MG Oral Powder | SY | 32ac719c-49f0-4105-9c46-18c19583a5c2 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52856-201-01 | 52856020101 | 1 in 1 PACKET | Historical | ||||
| 52856-201-03 | 52856020103 | 30 PACKET in 1 CARTON (52856-201-03) / 1 POWDER in 1 PACKET (52856-201-01) | 30 packet | 2025-07-28 | No | No | Current |