Prescription drug · NDA
Otezla (Apremilast) NDC 55513-519
Apremilast 75 mg/1 · Tablet, Film coated · Oral · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-519-30 | 5551305193055513051930 | 30 TABLET, FILM COATED in 1 BOTTLE (55513-519-30)Marketed from Aug 31, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Otezla
- Generic name (nonproprietary)
- apremilast
- Active ingredients
- Apremilast — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210745
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 55513-519_8d1d49ca-6dc1-4580-b2d5-f69ccb4f1c8eSPL ID 8d1d49ca-6dc1-4580-b2d5-f69ccb4f1c8eSPL set ID f6b1f516-4972-4d82-bced-113e47b41cc5RxCUI 1492732, 1492738, 1492740, 1492742, 1492744, 1492746, 1492747, 1492748, 1605454, 1605455, 2682429, 2682430, 2682431, 2682432, 2723448, 2723452, 2724366, 2724367UNII UP7QBP99PNUPC 0355513137607
- Pharmacologic class
- Phosphodiesterase 4 Inhibitor
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
N455513051930followed by a unit qualifier and the quantityPackage 55513-0519-30. 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 .
Indications (excerpt from the label)
OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis ( 1.1 ) Plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) Oral ulcers associated with Behçet's Disease ( 1.3 ) Pediatric patients 6 years of age and older with: Active psoriatic arthritis ( 1.1 ) Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. 1.1 Psoriatic Arthritis OTEZLA is indicated for the treatment of adult patie…
Excerpt only. Read the full label for complete information.
About NDC 55513-519
- What is NDC 55513-519?
- 55513-519 is the product NDC for Otezla (apremilast), Apremilast 75 mg/1 tablet, film coated, listed with the FDA by Amgen, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Otezla (Apremilast).
- What is the active ingredient?
- Apremilast.
- Who is the labeler?
- Amgen, Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Otezla?
- 7 other product NDCs are listed under this name. See all Otezla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Otezla products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Otezlaapremilast | — | Kit | Amgen, Inc | 55513-516 | 55513-0516-41 |
| Otezlaapremilast | Apremilast 20 mg/1 | Tablet, Film coatedOral | Amgen, Inc | 55513-497 | 55513-0497-60 |
| Otezlaapremilast | — | Kit | Amgen, Inc | 55513-508 | 55513-0508-55 |
| Otezlaapremilast | — | Kit | Amgen, Inc | 55513-996 | 55513-0996-95 |
| Otezlaapremilast | Apremilast 30 mg/1 | Tablet, Film coatedOral | Amgen, Inc | 55513-137 | 55513-0137-6055513-0137-95 |
| Otezlaapremilast | — | Kit | Amgen, Inc | 55513-369 | 55513-0369-55 |
| Otezlaapremilast | — | Kit | Amgen, Inc | 55513-485 | 55513-0485-96 |
Other NDCs under NDA 210745
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 |
|---|---|---|---|---|
| Otezlaapremilast | — | Kit | Amgen, Inc | 55513-516 |