Sephience
- Product NDC
- 60468-007
- 11-digit product format
- 604680007
- Labeler code
- 60468
- Product ID
- 60468-007_4031b751-a798-3024-e063-6294a90ac2b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEPIAPTERIN
- Dosage form
- POWDER
- Route
- ORAL
- Labeler
- allphamed Pharbil Arzneimittel GmbH
- Application
- NDA219666
- Marketing category
- NDA
- Marketing start
- 2025-07-28
- Substance
- SEPIAPTERIN
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sephience
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEPIAPTERIN | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CJQ26KO7HP |
| Rxcui | 2723061, 2723067, 2723069, 2723071 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60468-007-01 | Sephience | 1 in 1 PACKET | POWDER | 1 | | 1 |
| 60468-007-03 | Sephience | 30 in 1 CARTON | POWDER | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60468-007-01 | 60468000701 | 1 in 1 PACKET | | | | | Historical |
| 60468-007-03 | 60468000703 | 30 PACKET in 1 CARTON (60468-007-03) / 1 POWDER in 1 PACKET (60468-007-01) | 30 packet | 2025-07-28 | No | No | Current |