Prescription drug · NDA
Rykindo extended-release microspheres NDC 72526-104
risperidone · Kit · Shandong Luye Pharmaceutical Co., Ltd.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Rykindo extended-release microspheresSuffix: extended-release microspheres
- Generic name (nonproprietary)
- risperidone
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212849
- Marketing start
- Listing expires
- Identifiers
- Product ID 72526-104_4701fbbb-2d07-4b47-9596-4255a49c7dbcSPL ID 4701fbbb-2d07-4b47-9596-4255a49c7dbcSPL set ID 58534c96-96f5-4c2e-a061-92d4506aee91RxCUI 402010, 402011, 402012, 2639734, 2639736, 2639738
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
RYKINDO is indicated: for the treatment of schizophrenia in adults as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults RYKINDO is an atypical antipsychotic indicated: for the treatment of schizophrenia in adults. ( 1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212849
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 |
|---|---|---|---|---|
| Rykindo extended-release microspheresrisperidone | — | Kit | Shandong Luye Pharmaceutical Co., Ltd. | 72526-103 |
| Rykindo extended-release microspheresrisperidone | — | Kit | Shandong Luye Pharmaceutical Co., Ltd. | 72526-102 |