Risperidone
- Product NDC
- 67046-653
- 11-digit product format
- 670460653
- Labeler code
- 67046
- Product ID
- 67046-653_2e5c6b7f-1d57-4114-9067-79dca009c4cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Contract Pharmacy Services-PA
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2010-08-25
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 0 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67046-653-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c4a7-621f-e053-dbdaa90a74ad | These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. RISPERIDONE tablets, USP Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-653-30 | Risperidone | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312828 | risperiDONE 0.25 MG Oral Tablet | PSN | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312829 | risperiDONE 0.5 MG Oral Tablet | PSN | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312830 | risperiDONE 1 MG Oral Tablet | PSN | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312831 | risperiDONE 2 MG Oral Tablet | PSN | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312832 | risperiDONE 3 MG Oral Tablet | PSN | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 314211 | risperiDONE 4 MG Oral Tablet | PSN | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312828 | risperidone 0.25 MG Oral Tablet | SCD | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312829 | risperidone 0.5 MG Oral Tablet | SCD | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312830 | risperidone 1 MG Oral Tablet | SCD | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312831 | risperidone 2 MG Oral Tablet | SCD | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 312832 | risperidone 3 MG Oral Tablet | SCD | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
| 314211 | risperidone 4 MG Oral Tablet | SCD | 2e5c6b7f-1d57-4114-9067-79dca009c4cc | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 67046-653-30 | 67046065330 | 30 in 1 BLISTER PACK | Historical |