Risperidone
- Product NDC
- 84677-005
- 11-digit product format
- 846770005
- Labeler code
- 84677
- Product ID
- 84677-005_44846029-352f-2325-e063-6394a90a38a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA078828
- Marketing category
- ANDA
- Marketing start
- 2009-03-23
- Substance
- RISPERIDONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Risperidone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RISPERIDONE | 2 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312828, 312829, 312830, 312831, 312832, 314211 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6 | Product name | 5 | 20250303 |
| 0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e | Product name | 1 | 20250128 |
| e457a910-2c3a-4bfd-90b9-0310982c50dd | Product name | 1 | 20241218 |
| 42b1a2d5-888a-4386-ab9f-0979e0d7b4aa | Product name | 1 | 20231010 |
| 66685e90-862d-4873-a0c5-2be73b803c36 | Product name | 1 | 20230921 |
| 92d220a1-2a4c-4393-9080-7335ca8223cc | Product name | 1 | 20230823 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84677-005-05 | Risperidone | 500 in 1 BOTTLE | TABLET | 500 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312828 | risperiDONE 0.25 MG Oral Tablet | PSN | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312829 | risperiDONE 0.5 MG Oral Tablet | PSN | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312830 | risperiDONE 1 MG Oral Tablet | PSN | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312831 | risperiDONE 2 MG Oral Tablet | PSN | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312832 | risperiDONE 3 MG Oral Tablet | PSN | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 314211 | risperiDONE 4 MG Oral Tablet | PSN | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312828 | risperidone 0.25 MG Oral Tablet | SCD | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312829 | risperidone 0.5 MG Oral Tablet | SCD | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312830 | risperidone 1 MG Oral Tablet | SCD | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312831 | risperidone 2 MG Oral Tablet | SCD | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 312832 | risperidone 3 MG Oral Tablet | SCD | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
| 314211 | risperidone 4 MG Oral Tablet | SCD | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84677-005-05 | 84677000505 | 500 TABLET in 1 BOTTLE (84677-005-05) | 500 tablet | 2025-09-26 | No | No | Current |