Prescription drug · ANDA
Carbidopa-levodopa NDC 52817-390
carbidopa and levodopa · Carbidopa 10 mg/1; Levodopa 100 mg/1 · Tablet · Oral · TruPharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-390-10 | 52817039010 | 100 TABLET in 1 BOTTLE (52817-390-10)Marketed from Apr 4, 2023 | |
| 52817-390-50 | 52817039050 | 500 TABLET in 1 BOTTLE (52817-390-50)Marketed from Apr 4, 2023 |
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
- Generic name (nonproprietary)
- carbidopa and levodopa
- Active ingredients
- Carbidopa — 10 mg/1Levodopa — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TruPharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216505
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 52817-390_f8d2095e-d709-7b97-e053-6294a90af7d6SPL ID f8d2095e-d709-7b97-e053-6294a90af7d6SPL set ID d1bb319b-82a3-4b66-9cdc-f77fdb8383ceRxCUI 197443, 197444, 197445UNII MNX7R8C5VO, 46627O600JUPC 0352817390103, 0352817391506, 0352817392008, 0352817391100, 0352817390509, 0352817391001, 0352817392503
- 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
N452817039010followed by a unit qualifier and the quantityPackage 52817-0390-10. 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 216505
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-levodopacarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Coupler LLC | 67046-1507 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | Advagen Pharma Ltd., | 72888-106 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Advagen Pharma Ltd., | 72888-107 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Advagen Pharma Ltd., | 72888-108 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | TruPharma, LLC | 52817-391 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | TruPharma, LLC | 52817-392 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | American Health Packaging | 68002-100 |
| Carbidopa-levodopacarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2588 |