Prescription drug · ANDA
Risperidone NDC 70121-2628
Kit · Intramuscular · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-2628-5 | 70121262805 | 1 KIT in 1 CARTON (70121-2628-5) * 2 mL in 1 VIAL (70121-1353-1) * 2 mL in 1 SYRINGE (70121-2624-2)Marketed from Sep 8, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Risperidone
- Generic name (nonproprietary)
- risperidone
- Dosage form
- Kit
- Route
- Intramuscular
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218586
- Marketing start
- Listing expires
- Identifiers
- Product ID 70121-2628_88f28969-3a2c-4851-ab01-18be48a87355SPL ID 88f28969-3a2c-4851-ab01-18be48a87355SPL set ID d526af85-ee70-4657-a27e-d451027ffd9eRxCUI 402010, 402011, 402012, 706822UPC 0370121262756, 0370121262855, 0370121262558
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470121262805followed by a unit qualifier and the quantityPackage 70121-2628-05. 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)
Risperidone for extended-release injectable suspension is an atypical antipsychotic indicated: for the treatment of schizophrenia. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. ( 1.2 ) 1.1 Schizophrenia Risperidone for extended-release injectable suspension is indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder Risperidone for extended-release injectable suspension is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder [see Clinical Studies (14.2 , 14.3) ] .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218586
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 |
|---|---|---|---|---|
| Risperidone | — | KitIntramuscular | Amneal Pharmaceuticals LLC | 70121-2627 |
| Risperidone | — | KitSubcutaneous | Amneal Pharmaceuticals LLC | 70121-2625 |
| Risperidone | — | KitIntramuscular | Amneal Pharmaceuticals LLC | 70121-2626 |