Risperidone
- Product NDC
- 27808-002
- 11-digit product format
- 278080002
- Labeler code
- 27808
- Product ID
- 27808-002_0cc8cb14-5af8-475e-add9-f6cd3e9d7a38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA079059
- Marketing category
- ANDA
- Marketing start
- 2015-03-13
- Substance
- RISPERIDONE
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 199387 |
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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27808-002-01 | Risperidone | 30 mL in 1 BOTTLE, UNIT-DOSE | SOLUTION | 30 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 27808-002-01 | ML - Milliliter | 27808-002 | b42ed7d0-0aff-40f9-88d5-c918916e890b | 1 | 2021-03-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RISPERIDONE SOLUTION [TRIS PHARMA INC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | 104 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | 104 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | 104 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 4604052d-dbda-4535-b7b8-1bd72a129aca | 100 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | 4604052d-dbda-4535-b7b8-1bd72a129aca | 100 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | 4604052d-dbda-4535-b7b8-1bd72a129aca | 100 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | a0a21bec-68f0-444e-a611-d0602859410c | 19 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | a0a21bec-68f0-444e-a611-d0602859410c | 19 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | a0a21bec-68f0-444e-a611-d0602859410c | 19 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 5 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 5 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 5 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | dc8c6638-f487-49df-a265-78caa93e43d8 | 4 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | dc8c6638-f487-49df-a265-78caa93e43d8 | 4 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | dc8c6638-f487-49df-a265-78caa93e43d8 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 27808-002-01 | 27808000201 | 30 mL in 1 BOTTLE, UNIT-DOSE (27808-002-01) | 30 ml | 2015-03-13 | 0000-00-00 | No | No | Current |