Risperidone
- Product NDC
- 13107-123
- 11-digit product format
- 131070123
- Labeler code
- 13107
- Product ID
- 13107-123_a8e32e4d-cb0a-491b-acbd-2627068e3a70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA078269
- Marketing category
- ANDA
- Marketing start
- 2009-10-25
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 13107-123-05 | Risperidone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 13107-123-10 | Risperidone | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 3 |
| 13107-123-10 | Risperidone | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 3 |
| 13107-123-60 | 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 [AUROLIFE PHARMA LLC] | 3 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-123 | RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 3 | Legacy NDC, 4 package rows | 20120515_24a02cd6-667c-4e03-8055-aaa094567864.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 13107-123-05 | 13107012305 | 500 in 1 BOTTLE | Historical |
| 13107-123-10 | 13107012310 | 10 in 1 CARTON | Historical |
| 13107-123-60 | 13107012360 | 60 in 1 BOTTLE | Historical |