Risperidone
- Product NDC
- 53808-0876
- 11-digit product format
- 538080876
- Labeler code
- 53808
- Product ID
- 53808-0876_76437cab-3ca6-4e54-9c58-803f50404969
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA076288
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0876-2 | Risperidone | 60 in 1 BLISTER PACK | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0876 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20140415_5db40498-428b-43d2-b29d-d351bf709585.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0876-2 | 53808087602 | 60 in 1 BLISTER PACK | Historical |