Prescription drug · ANDA
carbidopa, levodopa and entacapone NDC 46708-796
Carbidopa 18.75 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-796-31 | 46708079631 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-796-31)Marketed from Feb 12, 2026 | |
| 46708-796-91 | 46708079691 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-796-91)Marketed from Feb 12, 2026 |
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)
- carbidopa, levodopa and entacapone
- Generic name (nonproprietary)
- carbidopa, levodopa and entacapone
- Active ingredients
- Carbidopa — 18.75 mg/1Levodopa — 75 mg/1Entacapone — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218535
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)Catechol O-Methyltransferase Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-796_9ff83838-b7d0-4eec-98f2-fcc85789a189SPL ID 9ff83838-b7d0-4eec-98f2-fcc85789a189SPL set ID 9ff83838-b7d0-4eec-98f2-fcc85789a189RxCUI 403850, 403851, 403852, 730988, 810083, 810090UNII 46627O600J, MNX7R8C5VO, 4975G9NM6TUPC 0346708797317, 0346708799311, 0346708800314, 0346708798314, 0346708796310, 0346708795313
- 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
N446708079631followed by a unit qualifier and the quantityPackage 46708-0796-31. 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 ANDA 218535
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 | Alembic Pharmaceuticals Inc. | 62332-795 |
| carbidopa, levodopa and entacapone | Carbidopa 31.25 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-798 |
| carbidopa, levodopa and entacapone | Carbidopa 18.75 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-796 |
| carbidopa, levodopa and entacapone | Carbidopa 25 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-797 |
| carbidopa, levodopa and entacapone | Carbidopa 37.5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-799 |
| carbidopa, levodopa and entacapone | Carbidopa 50 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-800 |
| carbidopa, levodopa and entacapone | Carbidopa 31.25 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-798 |
| carbidopa, levodopa and entacapone | Carbidopa 12.5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-795 |
| carbidopa, levodopa and entacapone | Carbidopa 25 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-797 |
| carbidopa, levodopa and entacapone | Carbidopa 37.5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-799 |
| carbidopa, levodopa and entacapone | Carbidopa 50 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-800 |