Prescription drug · ANDA
Carbidopa and Levodopa NDC 59651-458
Carbidopa 25 mg/1; Levodopa 250 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-458-01 | 59651045801 | 100 TABLET in 1 BOTTLE (59651-458-01)Marketed from Nov 28, 2022 | |
| 59651-458-05 | 59651045805 | 500 TABLET in 1 BOTTLE (59651-458-05)Marketed from Nov 28, 2022 | |
| 59651-458-99 | 59651045899 | 1000 TABLET in 1 BOTTLE (59651-458-99)Marketed from Nov 28, 2022 |
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 — 25 mg/1Levodopa — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216537
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 59651-458_7a87848d-1fcb-4df6-ac7c-b506cc8dc95aSPL ID 7a87848d-1fcb-4df6-ac7c-b506cc8dc95aSPL set ID 4ced8a05-27ac-463f-b331-387e473fdaa1RxCUI 197443, 197444, 197445UNII 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
N459651045801followed by a unit qualifier and the quantityPackage 59651-0458-01. 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 tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216537
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 250 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4134 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Coupler LLC | 67046-1689 |
| Carbidopa and Levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-456 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-457 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7498 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7499 |
| Carbidopa and Levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | Coupler LLC | 67046-1614 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4620 |