NDC codes

FDA NDC Directory
Product NDC (as listed)68682-310Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0310Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68682-310-016868203100168682031001100 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

N468682031001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metyrosine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MetyrosineMetyrosine 250 mg/1CapsuleOralDr. Reddy's Laboratories Inc.75907-16675907-0166-0175907-0166-30
metyrosineMetyrosine 250 mg/1CapsuleOralAmneal Pharmaceuticals LLC69238-162169238-1621-0169238-1621-03

Other NDCs under NDA 017871

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 017871
ProductStrengthForm · routeLabelerProduct NDC
DemsermetyrosineMetyrosine 250 mg/1CapsuleOralBausch Health US, LLC25010-305

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