Prescription drug · NDA
Metopirone (Metyrapone) NDC 68118-455
Metyrapone 250 mg/1 · Capsule, Gelatin coated · Oral · ESTEVE PHARMACEUTICALS, S.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68118-455-18 | 68118045518 | 18 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18)Marketed from Jan 25, 1962 |
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)
- Metopirone
- Generic name (nonproprietary)
- metyrapone
- Active ingredients
- Metyrapone — 250 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- ESTEVE PHARMACEUTICALS, S.A.NDC labeler code 68118
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 012911
- Marketing start
- Listing expires
- Other FDA classes
- Adrenal Steroid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 68118-455_522c880b-4112-b33c-e063-6294a90aa12aSPL ID 522c880b-4112-b33c-e063-6294a90aa12aSPL set ID 4046b167-7a46-8f4a-e063-6394a90a147fRxCUI 105450, 199772UNII ZS9KD92H6VUPC 0368118455182
- Pharmacologic class
- Adrenal Steroid 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
N468118045518followed by a unit qualifier and the quantityPackage 68118-0455-18. 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)
Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68118-455
- What is NDC 68118-455?
- 68118-455 is the product NDC for Metopirone (metyrapone), Metyrapone 250 mg/1 capsule, gelatin coated, listed with the FDA by ESTEVE PHARMACEUTICALS, S.A.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metopirone (Metyrapone).
- What is the active ingredient?
- Metyrapone.
- Who is the labeler?
- ESTEVE PHARMACEUTICALS, S.A., NDC labeler code 68118. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metopirone?
- 1 other product NDC are listed under this name. See all Metopirone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metopirone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metopironemetyrapone | Metyrapone 250 mg/1 | Capsule, Gelatin coatedOral | HRA Pharma Rare Diseases | 76336-455 | 76336-0455-18 |
Other NDCs under NDA 012911
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 |
|---|---|---|---|---|
| Metopironemetyrapone | Metyrapone 250 mg/1 | Capsule, Gelatin coatedOral | HRA Pharma Rare Diseases | 76336-455 |