RISPERDAL CONSTA
- Product NDC
- 50458-309
- 11-digit product format
- 504580309
- Labeler code
- 50458
- Product ID
- 50458-309_42dc490b-4117-142a-e063-6294a90aeb21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- KIT
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA021346
- Marketing category
- NDA
- Marketing start
- 2003-10-29
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RISPERDAL CONSTA
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 402010, 402011, 402012, 706822, 706825, 706827, 706829, 706831 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50458-309-11 | RISPERDAL CONSTA | 1 in 1 BOX | KIT | 1 | | 38 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| risperidone | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| risperidone | ACTIVE MOIETY | L6UH7ZF8HC | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| carboxymethylcellulose sodium | INACTIVE INGREDIENT | K679OBS311 | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| sodium phosphate, dibasic, heptahydrate | INACTIVE INGREDIENT | 70WT22SF4B | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-309 | RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] | 37 | Current NDC, Legacy NDC, 1 package rows | 20250417_bb34ee82-d2c2-43b8-ba21-2825c0954691.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-309-11 | 50458030911 | 1 KIT in 1 BOX (50458-309-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-309-01) | 1 kit | 2003-10-29 | 0000-00-00 | No | No | Current |