Prescription drug · NDA
Tasmar (Tolcapone) NDC 0187-0938
Tolcapone 100 mg/1 · Tablet, Film coated · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0938-01 | 00187093801 | 90 TABLET, FILM COATED in 1 BOTTLE (0187-0938-01)Marketed from Jul 27, 2004 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tasmar
- Generic name (nonproprietary)
- tolcapone
- Active ingredients
- Tolcapone — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020697
- Marketing start
- Listing expires
- Other FDA classes
- Catechol O-Methyltransferase Inhibitors (Mechanism)
- Identifiers
- Product ID 0187-0938_b5c3a96c-28c4-40b3-8b44-e977c4ca2a9cSPL ID b5c3a96c-28c4-40b3-8b44-e977c4ca2a9cSPL set ID a0e47a9d-78e7-4523-983a-aa259f221736RxCUI 153655, 200220UNII CIF6334OLYUPC 0301870938012
- Pharmacologic class
- Catechol-O-Methyltransferase 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
N400187093801followed by a unit qualifier and the quantityPackage 00187-0938-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS: TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because TASMAR, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, …
Excerpt only. Read the full label for complete information.
About NDC 0187-0938
- What is NDC 0187-0938?
- 0187-0938 is the product NDC for Tasmar (tolcapone), Tolcapone 100 mg/1 tablet, film coated, 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?
- Tasmar (Tolcapone).
- What is the active ingredient?
- Tolcapone.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tasmar?
- 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 020697
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 |
|---|---|---|---|---|
| Tolcapone | Tolcapone 100 mg/1 | Tablet, Film coatedOral | Oceanside Pharmaceuticals | 68682-938 |