Risperidone
- Product NDC
- 65162-673
- 11-digit product format
- 651620673
- Labeler code
- 65162
- Product ID
- 65162-673_bdd3de74-828c-406b-a179-343b4c24d1d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA091384
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- 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 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-673-84 | Risperidone | 30 mL in 1 BOTTLE | SOLUTION | 30 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-673-84 | ML - Milliliter | 65162-673 | ae35838a-cefb-497d-9fd5-d21f3297d915 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | RISPERIDONE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RISPERIDONE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | bc55f60a-8121-44bb-bdfc-1d311879ba4f | 23 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | bc55f60a-8121-44bb-bdfc-1d311879ba4f | 23 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | bc55f60a-8121-44bb-bdfc-1d311879ba4f | 23 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 3c9836aa-81cc-4759-a5e9-bb061bbbacc2 | 6 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | 3c9836aa-81cc-4759-a5e9-bb061bbbacc2 | 6 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | 3c9836aa-81cc-4759-a5e9-bb061bbbacc2 | 6 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | dae5ec58-85c1-4503-a6b8-56696dd1e6fc | 2 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | dae5ec58-85c1-4503-a6b8-56696dd1e6fc | 2 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | dae5ec58-85c1-4503-a6b8-56696dd1e6fc | 2 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 7d79e841-6316-450a-a44f-475d157eb1ec | 1 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | 7d79e841-6316-450a-a44f-475d157eb1ec | 1 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | 7d79e841-6316-450a-a44f-475d157eb1ec | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65162-673-84 | 65162067384 | 30 mL in 1 BOTTLE (65162-673-84) | 30 ml | 2011-05-31 | 0000-00-00 | No | No | Current |