Prescription drug · NDA
Rytary (Carbidopa and levodopa) NDC 64896-661
Levodopa 95 mg/1; Carbidopa hydrate 23.75 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-661-01 | 6489606610164896066101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)Marketed from Jan 12, 2015 | |
| 64896-661-09 | 6489606610964896066109 | 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09)Marketed from Jan 12, 2015 | |
| 64896-661-43 | 6489606614364896066143 | 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-43)Marketed from Jan 12, 2015 | |
| 64896-661-99 | 6489606619964896066199 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-99)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 — 95 mg/1Carbidopa hydrate — 23.75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 64896
- 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 64896-661_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 MNX7R8C5VO, 46627O600JUPC 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
N464896066101followed by a unit qualifier and the quantityPackage 64896-0661-01. 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.
About NDC 64896-661
- What is NDC 64896-661?
- 64896-661 is the product NDC for Rytary, Levodopa 95 mg/1; Carbidopa hydrate 23.75 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rytary (Carbidopa and Levodopa).
- What is the active ingredient?
- Levodopa, Carbidopa hydrate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 64896. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rytary?
- 3 other product NDCs are listed under this name. See all Rytary NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rytary products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rytarycarbidopa and levodopa | Levodopa 145 mg/1; Carbidopa hydrate 36.25 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-662 | 64896-0662-0164896-0662-0964896-0662-43+1 more |
| Rytarycarbidopa and levodopa | Levodopa 195 mg/1; Carbidopa hydrate 48.75 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-663 | 64896-0663-0164896-0663-0964896-0663-43+1 more |
| Rytarycarbidopa and levodopa | Levodopa 245 mg/1; Carbidopa hydrate 61.25 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-664 | 64896-0664-0164896-0664-43 |
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 |
|---|---|---|---|---|
| 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 48.75 mg/1; Levodopa 195 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4621 |
| Carbidopa and Levodopa | Carbidopa 23.75 mg/1; Levodopa 95 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4618 |
| Carbidopa and Levodopa | Carbidopa 36.25 mg/1; Levodopa 145 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4630 |
| 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 195 mg/1; Carbidopa hydrate 48.75 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-663 |
| Rytarycarbidopa and levodopa | Levodopa 245 mg/1; Carbidopa hydrate 61.25 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-664 |