Prescription drug · NDA
Rytary NDC 64896-663
carbidopa and levodopa · Levodopa 195 mg/1; Carbidopa hydrate 48.75 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-663-01 | 64896066301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-01)Marketed from Jan 12, 2015 | |
| 64896-663-09 | 64896066309 | 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-09)Marketed from Jan 12, 2015 | |
| 64896-663-43 | 64896066343 | 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-43)Marketed from Jan 12, 2015 | |
| 64896-663-99 | 64896066399 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-99)Marketed from Jan 12, 2015 |
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)
- Rytary
- Generic name (nonproprietary)
- carbidopa and levodopa
- Active ingredients
- Levodopa — 195 mg/1Carbidopa hydrate — 48.75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203312
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 64896-663_ef3fe5ab-c753-409b-a5f3-b55e3eefd070SPL ID ef3fe5ab-c753-409b-a5f3-b55e3eefd070SPL set ID 6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7RxCUI 1600773, 1600774, 1600775, 1600776, 1600914, 1600915, 1600916, 1600917UNII 46627O600J, MNX7R8C5VOUPC 0364896663016, 0364896664013, 0364896662019, 0364896661012
- 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
N464896066301followed by a unit qualifier and the quantityPackage 64896-0663-01. 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)
RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. RYTARY 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. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203312
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 |
|---|---|---|---|---|
| Rytarycarbidopa and levodopa | Levodopa 245 mg/1; Carbidopa hydrate 61.25 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-664 |
| Rytarycarbidopa and levodopa | Levodopa 145 mg/1; Carbidopa hydrate 36.25 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-662 |
| Rytarycarbidopa and levodopa | Levodopa 95 mg/1; Carbidopa hydrate 23.75 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-661 |
| Carbidopa and Levodopa | Carbidopa 61.25 mg/1; Levodopa 245 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2142 |
| Carbidopa and Levodopa | Carbidopa 23.75 mg/1; Levodopa 95 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2139 |
| Carbidopa and Levodopa | Carbidopa 36.25 mg/1; Levodopa 145 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2140 |
| Carbidopa and Levodopa | Carbidopa 48.75 mg/1; Levodopa 195 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-2141 |
| Carbidopa and Levodopa | Carbidopa 61.25 mg/1; Levodopa 245 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4610 |
| Carbidopa and Levodopa | Carbidopa 23.75 mg/1; Levodopa 95 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4618 |
| Carbidopa and Levodopa | Carbidopa 48.75 mg/1; Levodopa 195 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4621 |
| Carbidopa and Levodopa | Carbidopa 36.25 mg/1; Levodopa 145 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4630 |