Prescription drug · NDA
Mycapssa (octreotide) NDC 69880-120
Octreotide 20 mg/1 · Capsule, Delayed release · Oral · Amryt Pharmaceuticals Designated Activity Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69880-120-28 | 69880012028 | 4 BLISTER PACK in 1 DOSE PACK (69880-120-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jul 6, 2020 |
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)
- Mycapssa
- Generic name (nonproprietary)
- octreotide
- Active ingredients
- Octreotide — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208232
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69880-120_1f0f9540-123a-49d7-b1d2-0c150dd5f26aSPL ID 1f0f9540-123a-49d7-b1d2-0c150dd5f26aSPL set ID 62a5e1eb-b48e-4ea6-8781-f75e490b17e4RxCUI 2380611, 2380617UNII RWM8CCW8GP
- Pharmacologic class
- Somatostatin Analog
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
N469880012028followed by a unit qualifier and the quantityPackage 69880-0120-28. 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)
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208232
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 |
|---|---|---|---|---|
| Mycapssaoctreotide | Octreotide 20 mg/1 | Capsule, Delayed releaseOral | Chiesi USA, Inc. | 10122-550 |