Prescription drug · ANDA
Carbidopa and Levodopa NDC 77771-461
Carbidopa 50 mg/1; Levodopa 200 mg/1 · Tablet, Extended release · Oral · Radha Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77771-461-01 | 77771046101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (77771-461-01)Marketed from Apr 25, 2025 |
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 and Levodopa
- Generic name (nonproprietary)
- carbidopa and levodopa
- Active ingredients
- Carbidopa — 50 mg/1Levodopa — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Radha Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214091
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 77771-461_2122b915-f36b-40d3-aaba-c50a3e8229c6SPL ID 2122b915-f36b-40d3-aaba-c50a3e8229c6SPL set ID 33a22ffe-0d41-162d-e063-6394a90a43d3RxCUI 308988, 308989UNII 46627O600J, MNX7R8C5VOUPC 0377771461010, 0377771460013
- Pharmacologic class
- Aromatic Amino Acid
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
N477771046101followed by a unit qualifier and the quantityPackage 77771-0461-01. 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)
INDICATIONS AND USAGE Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214091
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 and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Radha Pharmaceuticals Inc | 77771-460 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2194 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2193 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8460 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8461 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals Inc | 50228-460 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals Inc | 50228-461 |