Risperidone
- Product NDC
- 21695-072
- 11-digit product format
- 216950072
- Labeler code
- 21695
- Product ID
- 21695-072_2e8fb017-8754-421a-a76a-c41b8f48070b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA079088
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- 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 |
|---|---|---|---|---|---|
| 21695-072-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49ce-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE. RISPERIDONE tablet for oral use Risperidone Tablets, USP Initial U.S. Approval: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-072-60 | Risperidone | 60 in 1 BLISTER PACK | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-072-60 | EA - Each | 21695-072 | d6163bad-5e96-45fd-94e7-df4175ae5729 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312828 | risperiDONE 0.25 MG Oral Tablet | PSN | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312829 | risperiDONE 0.5 MG Oral Tablet | PSN | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312830 | risperiDONE 1 MG Oral Tablet | PSN | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312831 | risperiDONE 2 MG Oral Tablet | PSN | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312832 | risperiDONE 3 MG Oral Tablet | PSN | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312828 | risperidone 0.25 MG Oral Tablet | SCD | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312829 | risperidone 0.5 MG Oral Tablet | SCD | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312830 | risperidone 1 MG Oral Tablet | SCD | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312831 | risperidone 2 MG Oral Tablet | SCD | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
| 312832 | risperidone 3 MG Oral Tablet | SCD | 2e8fb017-8754-421a-a76a-c41b8f48070b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-072-60 | 21695007260 | 60 in 1 BLISTER PACK | Historical |