Prescription drug · ANDA
Carbidopa and Levodopa NDC 0615-8460
Carbidopa 25 mg/1; Levodopa 100 mg/1 · Tablet, Extended release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8460-39 | 00615846039 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8460-39)Marketed from Mar 28, 2023 |
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 and Levodopa
- Generic name (nonproprietary)
- carbidopa and levodopa
- Active ingredients
- Carbidopa — 25 mg/1Levodopa — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- 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 0615-8460_bd08f206-2051-4ac7-b4ac-b0b83a79029dSPL ID bd08f206-2051-4ac7-b4ac-b0b83a79029dSPL set ID ef0be743-e6f3-4662-8b0c-53f1eda4638aRxCUI 308988, 308989UNII 46627O600J, MNX7R8C5VO
- 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
N400615846039followed by a unit qualifier and the quantityPackage 00615-8460-39. 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 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Radha Pharmaceuticals Inc | 77771-461 |
| 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 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 |