Prescription drug · NDA
Sohonos (palovarotene) NDC 15054-0015
Palovarotene 1.5 mg/1 · Capsule · Oral · Ipsen Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15054-0015-1 | 15054001501 | 1 BLISTER PACK in 1 CARTON (15054-0015-1) / 14 CAPSULE in 1 BLISTER PACKMarketed from Aug 16, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sohonos
- Generic name (nonproprietary)
- palovarotene
- Active ingredients
- Palovarotene — 1.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215559
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 15054-0015_91754786-5967-4f1a-90fc-e070366bf0f1SPL ID 91754786-5967-4f1a-90fc-e070366bf0f1SPL set ID 67dce406-7cc4-4d66-92de-ad18b6df0625RxCUI 2663960, 2663966, 2663968, 2663970, 2663972, 2663974, 2663976, 2663978, 2663980, 2663982UNII 28K6I5M16G
- Pharmacologic class
- Retinoid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N415054001501followed by a unit qualifier and the quantityPackage 15054-0015-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is a retinoid indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP) ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 215559
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sohonospalovarotene | Palovarotene 1 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0010 |
| Sohonospalovarotene | Palovarotene 2.5 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0025 |
| Sohonospalovarotene | Palovarotene 5 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0050 |
| Sohonospalovarotene | Palovarotene 10 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0100 |