Prescription drug · NDA
Demser (Metyrosine) NDC 25010-305
Metyrosine 250 mg/1 · Capsule · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25010-305-15 | 2501003051525010030515 | 100 CAPSULE in 1 BOTTLE (25010-305-15)Marketed from Oct 3, 1979 |
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)
- Demser
- Generic name (nonproprietary)
- metyrosine
- Active ingredients
- Metyrosine — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bausch Health US, LLCNDC labeler code 25010
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017871
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamine Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 25010-305_7997d826-eb49-4688-9833-e668985c1e74SPL ID 7997d826-eb49-4688-9833-e668985c1e74SPL set ID 32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92RxCUI 197980, 201388UNII DOQ0J0TPF7
- Pharmacologic class
- Catecholamine Synthesis 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
N425010030515followed by a unit qualifier and the quantityPackage 25010-0305-15. 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)
INDICATIONS AND USAGE DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
Excerpt only. Read the full label for complete information.
About NDC 25010-305
- What is NDC 25010-305?
- 25010-305 is the product NDC for Demser (metyrosine), Metyrosine 250 mg/1 capsule, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Demser (Metyrosine).
- What is the active ingredient?
- Metyrosine.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 25010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Demser?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 017871
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 |
|---|---|---|---|---|
| Metyrosine | Metyrosine 250 mg/1 | CapsuleOral | Oceanside Pharmaceuticals | 68682-310 |