Prescription drug · NDA
Camzyos (mavacamten) NDC 73625-112
Mavacamten 5 mg/1 · Capsule, Gelatin coated · Oral · Myokardia, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73625-112-11 | 73625011211 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-112-11)Marketed from Apr 28, 2022 |
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)
- Camzyos
- Generic name (nonproprietary)
- mavacamten
- Active ingredients
- Mavacamten — 5 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Myokardia, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214998
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Myosin Inhibitors (Mechanism)
- Identifiers
- Product ID 73625-112_85338960-904b-44df-908f-b74b62902779SPL ID 85338960-904b-44df-908f-b74b62902779SPL set ID 669c936b-3ee6-4e36-8a22-79dd11b1255bRxCUI 2600872, 2600878, 2600880, 2600882, 2600884, 2600886, 2600888, 2600890UNII QX45B99R3J
- Pharmacologic class
- Cardiac Myosin 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
N473625011211followed by a unit qualifier and the quantityPackage 73625-0112-11. 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)
CAMZYOS ® is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. CAMZYOS is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 214998
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 |
|---|---|---|---|---|
| Camzyosmavacamten | Mavacamten 2.5 mg/1 | Capsule, Gelatin coatedOral | Myokardia, Inc. | 73625-111 |
| Camzyosmavacamten | Mavacamten 10 mg/1 | Capsule, Gelatin coatedOral | Myokardia, Inc. | 73625-113 |
| Camzyosmavacamten | Mavacamten 15 mg/1 | Capsule, Gelatin coatedOral | Myokardia, Inc. | 73625-114 |