Prescription drug · NDA
Lysodren (Mitotane) NDC 68118-080
Mitotane 500 mg/1 · Tablet · Oral · ESTEVE PHARMACEUTICALS, S.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68118-080-60 | 68118008060 | 1 BOTTLE in 1 CARTON (68118-080-60) / 100 TABLET in 1 BOTTLEMarketed from Oct 15, 1978 |
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)
- Lysodren
- Generic name (nonproprietary)
- mitotane
- Active ingredients
- Mitotane — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ESTEVE PHARMACEUTICALS, S.A.NDC labeler code 68118
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016885
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inducers (Mechanism)
- Identifiers
- Product ID 68118-080_58257b74-15bb-d5d5-e063-6394a90accc7SPL ID 58257b74-15bb-d5d5-e063-6394a90accc7SPL set ID 4046a224-8832-daa2-e063-6294a90a11d7RxCUI 197988, 207373UNII 78E4J5IB5JUPC 0368118080605
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
N468118008060followed by a unit qualifier and the quantityPackage 68118-0080-60. 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)
LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68118-080
- What is NDC 68118-080?
- 68118-080 is the product NDC for Lysodren (mitotane), Mitotane 500 mg/1 tablet, 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?
- Lysodren (Mitotane).
- What is the active ingredient?
- Mitotane.
- 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 Lysodren?
- 1 other product NDC are listed under this name. See all Lysodren NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lysodren products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lysodrenmitotane | Mitotane 500 mg/1 | TabletOral | HRA Pharma Rare Diseases | 76336-080 | 76336-0080-60 |
Other NDCs under NDA 016885
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 |
|---|---|---|---|---|
| Lysodrenmitotane | Mitotane 500 mg/1 | TabletOral | HRA Pharma Rare Diseases | 76336-080 |