Prescription drug · ANDA
Carbidopa and levodopa NDC 42291-488
Carbidopa 25 mg/1; Levodopa 250 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-488-01 | 42291048801 | 100 TABLET in 1 BOTTLE (42291-488-01)Marketed from Feb 21, 2024 | |
| 42291-488-10 | 42291048810 | 1000 TABLET in 1 BOTTLE (42291-488-10)Marketed from Feb 21, 2024 |
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
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074260
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 42291-488_485f790b-2d36-cffd-e063-6294a90a1cb7SPL ID 485f790b-2d36-cffd-e063-6294a90a1cb7SPL set ID 11e706c4-433c-1ea6-e063-6294a90ad360RxCUI 197445UNII MNX7R8C5VO, 46627O600J
- 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
N442291048801followed by a unit qualifier and the quantityPackage 42291-0488-01. 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. 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 may also…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074260
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 hydrate 25 mg/1; Levodopa 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-9702 |
| Carbidopa and levodopa | Carbidopa hydrate 10 mg/1; Levodopa 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-9701 |
| Carbidopa and levodopa | Carbidopa hydrate 25 mg/1; Levodopa 250 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-9703 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | American Health Packaging | 60687-836 |
| Carbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6727 |
| Carbidopa and levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | AvKARE | 42291-471 |
| Carbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | AvKARE | 42291-472 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | American Health Packaging | 60687-661 |
| Carbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-664 |