Prescription drug · ANDA
Carbidopa and Levodopa NDC 51079-978
Carbidopa 25 mg/1; Levodopa 100 mg/1 · Tablet, Extended release · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-978-20 | 51079097820 | 100 BLISTER PACK in 1 CARTON (51079-978-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-978-01)Marketed from Feb 1, 2002 |
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
- Mylan Institutional Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075091
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 51079-978_3a39bb13-44d1-2652-e063-6294a90ad211SPL ID 3a39bb13-44d1-2652-e063-6294a90ad211SPL set ID 16f9e4d1-6953-4d4f-b4cf-ad95a856ac25RxCUI 308988, 308989UNII 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
N451079097820followed by a unit qualifier and the quantityPackage 51079-0978-20. 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 075091
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 | Tablet, Extended releaseOral | Safecor Health, LLC | 48433-015 |
| Carbidopa and Levodopa | Carbidopa hydrate 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Safecor Health, LLC | 48433-016 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-0088 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-0094 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Mylan Institutional Inc. | 51079-923 |