Prescription drug · NDA AUTHORIZED GENERIC
Carbidopa, Levodopa, and Entacapone NDC 0781-5654
Carbidopa 37.5 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5654-01 | 00781565401 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01)Marketed from Jun 18, 2014 |
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)
- Carbidopa, Levodopa, and Entacapone
- Generic name (nonproprietary)
- carbidopa, levodopa, and entacapone
- Active ingredients
- Carbidopa — 37.5 mg/1Levodopa — 150 mg/1Entacapone — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021485
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)Catechol O-Methyltransferase Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-5654_2176ea25-da6b-47b2-a081-b3da614df0a0SPL ID 2176ea25-da6b-47b2-a081-b3da614df0a0SPL set ID 9c16c0e0-3b97-486b-b7d5-579f5853e2c5RxCUI 403850, 403851, 403852, 730988, 810083, 810090UNII 46627O600J, MNX7R8C5VO, 4975G9NM6TUPC 0307815625016
- Pharmacologic class
- Aromatic Amino Acid; 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
N400781565401followed by a unit qualifier and the quantityPackage 00781-5654-01. 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)
Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aroma…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021485
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 |
|---|---|---|---|---|
| Carbidopa, Levodopa, and Entacapone | Carbidopa 12.5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Sandoz Inc | 0781-5613 |
| Carbidopa, Levodopa, and Entacapone | Carbidopa 18.75 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Sandoz Inc | 0781-5625 |
| Carbidopa, Levodopa, and Entacapone | Carbidopa 25 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Sandoz Inc | 0781-5637 |
| Carbidopa, Levodopa, and Entacapone | Carbidopa 31.25 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Sandoz Inc | 0781-5641 |
| Carbidopa, Levodopa, and Entacapone | Carbidopa 50 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Sandoz Inc | 0781-5669 |