Prescription drug · ANDA
Risperidone NDC 84677-003
Risperidone .5 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84677-003-05 | 84677000305 | 500 TABLET in 1 BOTTLE (84677-003-05)Marketed from Sep 26, 2025 |
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)
- Risperidone
- Generic name (nonproprietary)
- risperidone
- Active ingredients
- Risperidone — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078828
- Marketing start
- Listing expires
- Identifiers
- Product ID 84677-003_44846029-352f-2325-e063-6394a90a38a4SPL ID 44846029-352f-2325-e063-6394a90a38a4SPL set ID 448467a3-44ef-c87b-e063-6294a90a5ec9RxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII L6UH7ZF8HC
- Pharmacologic class
- Atypical Antipsychotic
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
N484677000305followed by a unit qualifier and the quantityPackage 84677-0003-05. 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 is atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ] . 1.2 Bipolar Mania Monotherapy Risperidone tablets are indicated for the treatment of acute manic or mix…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078828
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 | Risperidone 1 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-223 |
| Risperidone | Risperidone .25 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-221 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-222 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-224 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-225 |
| Risperidone | Risperidone 4 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-226 |
| Risperidone | Risperidone .25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 84677-002 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 84677-006 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 84677-004 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 84677-005 |
| Risperidone | Risperidone 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 84677-007 |