Risperidone
- Product NDC
- 68084-272
- 11-digit product format
- 680840272
- Labeler code
- 68084
- Product ID
- 68084-272_43e5e95c-ad0c-3657-e063-6394a90af632
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2008-12-02
- Substance
- RISPERIDONE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312828, 312829, 312830, 312831, 312832, 314211 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-272-01 | Risperidone | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 16 |
| 68084-272-11 | Risperidone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-272 | RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 15 | Current NDC, Legacy NDC, 2 package rows | 20250104_f11dae15-b057-4258-9229-3819d0c980fe.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 |
|---|
| 68084-272-01 | 68084027201 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-272-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-272-11) | 100 blister pack | 2008-12-02 | 0000-00-00 | No | No | Current |
| 68084-272-11 | 68084027211 | 1 in 1 BLISTER PACK | | | | | | Historical |