Risperidone
- Product NDC
- 43353-754
- 11-digit product format
- 433530754
- Labeler code
- 43353
- Product ID
- 43353-754_9139290e-82d1-40ea-afbe-4fd7be934799
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076288
- Marketing category
- ANDA
- Marketing start
- 2008-09-17
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 4 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 |
|---|
| 43353-754-15 | Risperidone | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 3 |
| 43353-754-16 | Risperidone | 6000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6000 | | 3 |
| 43353-754-30 | Risperidone | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 43353-754-45 | Risperidone | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 3 |
| 43353-754-60 | Risperidone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-754 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 5 package rows | 20140509_50aec836-fbfd-49af-9448-912b8279a7f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-754-15 | 43353075415 | 15 in 1 BOTTLE, PLASTIC | Historical |
| 43353-754-16 | 43353075416 | 6000 in 1 BOTTLE, PLASTIC | Historical |
| 43353-754-30 | 43353075430 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 43353-754-45 | 43353075445 | 45 in 1 BOTTLE, PLASTIC | Historical |
| 43353-754-60 | 43353075460 | 90 in 1 BOTTLE, PLASTIC | Historical |