Prescription drug · ANDA
Carbidopa and Levodopa NDC 16571-158
Carbidopa 25 mg/1; Levodopa 100 mg/1 · Tablet, Orally disintegrating · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-158-01 | 16571015801 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-158-01)Marketed from Jan 8, 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 — 25 mg/1Levodopa — 100 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078893
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 16571-158_bf8b1cec-9b24-4102-b948-08c988bfca91SPL ID bf8b1cec-9b24-4102-b948-08c988bfca91SPL set ID 302bfe03-d222-4a87-80ff-f2dbfb9a07f4RxCUI 476399, 476515, 483090UNII 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
N416571015801followed by a unit qualifier and the quantityPackage 16571-0158-01. 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 orally disintegrating 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 orally disintegrating 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 th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078893
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 10 mg/1; Levodopa 100 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 16571-157 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 16571-159 |