Prescription drug · NDA
Rykindo extended-release microspheres NDC 72526-102
risperidone · Kit · Shandong Luye Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72526-102-11 | 72526010211 | 1 KIT in 1 KIT (72526-102-11) * 2 mL in 1 VIAL, SINGLE-DOSE (72526-202-01) * 2 mL in 1 SYRINGE, GLASS (72526-801-01)Marketed from Jun 20, 2023 |
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)
- 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 72526-102_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.
- NDC on a medical claim
N472526010211followed by a unit qualifier and the quantityPackage 72526-0102-11. 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 . 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. | 72526-104 |