Prescription drug · ANDA
Carbidopa And Levodopa NDC 16729-078
Carbidopa 25 mg/1; Levodopa 100 mg/1 · Tablet, Extended release · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-078-01 | 16729007801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01)Marketed from Jun 13, 2013 | |
| 16729-078-17 | 16729007817 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17)Marketed from Oct 31, 2013 |
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, Extended release
- Route
- Oral
- Labeler
- Accord Healthcare, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202323
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 16729-078_40a9fe53-d24b-d4ad-e063-6294a90aeff5SPL ID 40a9fe53-d24b-d4ad-e063-6294a90aeff5SPL set ID 5217a6ec-cc26-4acc-b2da-17f6545c3b60RxCUI 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
N416729007801followed by a unit qualifier and the quantityPackage 16729-0078-01. 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 extended-release 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202323
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 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Accord Healthcare, Inc. | 16729-079 |