Prescription drug · NDA AUTHORIZED GENERIC
Metyrosine NDC 68682-310
Metyrosine 250 mg/1 · Capsule · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-310-01 | 6868203100168682031001 | 100 CAPSULE in 1 BOTTLE (68682-310-01)Marketed from Sep 7, 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)
- Metyrosine
- Generic name (nonproprietary)
- metyrosine
- Active ingredients
- Metyrosine — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Oceanside PharmaceuticalsNDC labeler code 68682
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017871
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamine Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 68682-310_e61c29ce-16b2-415c-b203-28bc9d45bb5fSPL ID e61c29ce-16b2-415c-b203-28bc9d45bb5fSPL set ID 46612725-bee0-4125-b8b5-9fed9c003ed4RxCUI 197980UNII 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
N468682031001followed by a unit qualifier and the quantityPackage 68682-0310-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Metyrosine 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 Metyrosine is not recommended for the control of essential hypertension.
Excerpt only. Read the full label for complete information.
About NDC 68682-310
- What is NDC 68682-310?
- 68682-310 is the product NDC for Metyrosine, Metyrosine 250 mg/1 capsule, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metyrosine.
- What is the active ingredient?
- Metyrosine.
- Who is the labeler?
- Oceanside Pharmaceuticals, NDC labeler code 68682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metyrosine?
- 2 other product NDCs are listed under this name. See all Metyrosine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metyrosine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metyrosine | Metyrosine 250 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc. | 75907-166 | 75907-0166-0175907-0166-30 |
| metyrosine | Metyrosine 250 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 69238-1621 | 69238-1621-0169238-1621-03 |
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 |
|---|---|---|---|---|
| Demsermetyrosine | Metyrosine 250 mg/1 | CapsuleOral | Bausch Health US, LLC | 25010-305 |