SOHONOS
- Product NDC
- 15054-0025
- 11-digit product format
- 150540025
- Labeler code
- 15054
- Product ID
- 15054-0025_5bd9a571-7061-4cc7-bda8-18a9976dd427
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palovarotene
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ipsen Biopharmaceuticals, Inc.
- Application
- NDA215559
- Marketing category
- NDA
- Marketing start
- 2023-08-16
- Substance
- PALOVAROTENE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SOHONOS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALOVAROTENE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 28K6I5M16G |
| Rxcui | 2663960, 2663966, 2663968, 2663970, 2663972, 2663974, 2663976, 2663978, 2663980, 2663982 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15054-0025-1 | SOHONOS | 14 in 1 BLISTER PACK | CAPSULE | 14 | | 2 |
| 15054-0025-1 | SOHONOS | 1 in 1 CARTON | CAPSULE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15054-0025 | SOHONOS (PALOVAROTENE) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250323_67dce406-7cc4-4d66-92de-ad18b6df0625.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 15054-0025-1 | 15054002501 | 1 BLISTER PACK in 1 CARTON (15054-0025-1) / 14 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2023-08-16 | No | No | Current |