Prescription drug · ANDA
Carbidopa and Levodopa NDC 50228-458
Carbidopa 25 mg/1; Levodopa 100 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-458-01 | 50228045801 | 100 TABLET in 1 BOTTLE (50228-458-01)Marketed from May 7, 2021 | |
| 50228-458-05 | 50228045805 | 500 TABLET in 1 BOTTLE (50228-458-05)Marketed from May 7, 2021 | |
| 50228-458-10 | 50228045810 | 1000 TABLET in 1 BOTTLE (50228-458-10)Marketed from May 7, 2021 | |
| 50228-458-30 | 50228045830 | 30 TABLET in 1 BOTTLE (50228-458-30)Marketed from May 7, 2021 |
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
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214092
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 50228-458_3b66d16c-654c-4dcb-ad04-3503aa7f1ca5SPL ID 3b66d16c-654c-4dcb-ad04-3503aa7f1ca5SPL set ID a32afa84-7bc0-4bd3-bc50-55d738f3d7ceRxCUI 197443, 197444, 197445UNII 46627O600J, MNX7R8C5VOUPC 0350228458054, 0350228459303, 0350228459051, 0350228458016, 0350228459013, 0350228457057, 0350228458108, 0350228457019, 0350228458306, 0350228457309
- 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
N450228045801followed by a unit qualifier and the quantityPackage 50228-0458-01. 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 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 214092
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 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-338 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-339 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-340 |
| Carbidopa and Levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | Proficient Rx LP | 71205-877 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6725 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Proficient Rx LP | 71205-878 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Proficient Rx LP | 71205-879 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-5969 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Coupler LLC | 67046-1450 |
| Carbidopa and Levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7186 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-647 |
| Carbidopa and Levodopa | Carbidopa 10 mg/1; Levodopa 100 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-457 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6580 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-459 |