Prescription drug · NDA
Crexont NDC 64896-969
carbidopa and levodopa · Carbidopa hydrate 70 mg/1; Levodopa 280 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-969-16 | 64896096916 | 1 BOTTLE in 1 CARTON (64896-969-16) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 9, 2024 | |
| 64896-969-23 | 64896096923 | 1 BOTTLE in 1 CARTON (64896-969-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 9, 2024 · Sample package |
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)
- Crexont
- Generic name (nonproprietary)
- carbidopa and levodopa
- Active ingredients
- Carbidopa hydrate — 70 mg/1Levodopa — 280 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217186
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 64896-969_61f8ee81-fe48-4f07-8c6b-aad4701c7f8bSPL ID 61f8ee81-fe48-4f07-8c6b-aad4701c7f8bSPL set ID 095a08b6-b0b8-4f88-b759-67e8b87287a0RxCUI 2690259, 2690265, 2690279, 2690281, 2690284, 2690286, 2690290, 2690292UNII MNX7R8C5VO, 46627O600JUPC 0364896968166, 0364896969163, 0364896967169
- 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
N464896096916followed by a unit qualifier and the quantityPackage 64896-0969-16. 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)
CREXONT is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. CREXONT is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 217186
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 |
|---|---|---|---|---|
| Crexontcarbidopa and levodopa | Carbidopa hydrate 87.5 mg/1; Levodopa 350 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-970 |
| Crexontcarbidopa and levodopa | Carbidopa hydrate 35 mg/1; Levodopa 140 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-967 |
| Crexontcarbidopa and levodopa | Carbidopa hydrate 52.5 mg/1; Levodopa 210 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-968 |