risperidone
- Product NDC
- 63187-418
- 11-digit product format
- 631870418
- Labeler code
- 63187
- Product ID
- 63187-418_71435439-971d-4db3-89d2-71b74b10f57c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2008-11-13
- Substance
- RISPERIDONE
- Active strength
- .25 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 table| Ingredient | Strength |
|---|
| RISPERIDONE | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312828 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-418-60 | risperidone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-418 | RISPERIDONE TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210115_b611fe52-1787-47e6-8a6b-1999a4e4f22c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-418-60 | 63187041860 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-418-60) | 2019-01-01 | 0000-00-00 | No | No | Current |