Prescription drug · NDA
Sohonos (Palovarotene) NDC 15054-0050
Palovarotene 5 mg/1 · Capsule · Oral · Ipsen Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15054-0050-1 | 1505400500115054005001 | 1 BLISTER PACK in 1 CARTON (15054-0050-1) / 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 — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ipsen Biopharmaceuticals, Inc.NDC labeler code 15054
- 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 15054-0050_cf7687df-422d-4e5d-a576-c11767f3f485SPL ID cf7687df-422d-4e5d-a576-c11767f3f485
- 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
N415054005001followed by a unit qualifier and the quantityPackage 15054-0050-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 15054-0050
- What is NDC 15054-0050?
- 15054-0050 is the product NDC for Sohonos (palovarotene), Palovarotene 5 mg/1 capsule, listed with the FDA by Ipsen Biopharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sohonos (Palovarotene).
- What is the active ingredient?
- Palovarotene.
- Who is the labeler?
- Ipsen Biopharmaceuticals, Inc., NDC labeler code 15054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sohonos?
- 4 other product NDCs are listed under this name. See all Sohonos NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sohonos products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sohonospalovarotene | Palovarotene 1 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0010 | 15054-0010-01 |
| Sohonospalovarotene | Palovarotene 1.5 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0015 | 15054-0015-01 |
| Sohonospalovarotene | Palovarotene 2.5 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0025 | 15054-0025-01 |
| Sohonospalovarotene | Palovarotene 10 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0100 | 15054-0100-01 |
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 1.5 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0015 |
| Sohonospalovarotene | Palovarotene 2.5 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0025 |
| Sohonospalovarotene | Palovarotene 10 mg/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-0100 |