FDA.reportPublic FDA data

Risperidone

Product NDC
43547-340
11-digit product format
435470340
Labeler code
43547
Product ID
43547-340_96d2f276-6bf9-4dfd-8831-888ca0c5c5b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA077493
Marketing category
ANDA
Marketing start
2014-06-01
Substance
RISPERIDONE
Active strength
.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Risperidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6Product name520250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09eProduct name120250128
e457a910-2c3a-4bfd-90b9-0310982c50ddProduct name120241218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-340-062020-03-10C16284748780-19d75b9d0-7a08-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993
43547-340-502020-03-10C16284748780-19d75b9d0-7a08-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993
43547-340-062020-01-31C16284748780-19d75b9d0-7a08-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993
43547-340-502020-01-31C16284748780-19d75b9d0-7a08-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-340-06Risperidone60 in 1 BOTTLETABLET6014
43547-340-50Risperidone500 in 1 BOTTLETABLET50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-340-06EA - Each43547-340b145b967-ba61-4a1f-99b6-c7bbad4d530d12015-08-04
43547-340-50EA - Each43547-340a655d15f-b787-44a0-bf8b-ce539ffe4d7b12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RisperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
RisperidoneACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-340RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]13Current NDC, Legacy NDC, 2 package rows20250328_43aa2a4f-1123-4f86-800b-9218882f7bcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN43aa2a4f-1123-4f86-800b-9218882f7bcd14
312829risperiDONE 0.5 MG Oral TabletPSN43aa2a4f-1123-4f86-800b-9218882f7bcd14
312830risperiDONE 1 MG Oral TabletPSN43aa2a4f-1123-4f86-800b-9218882f7bcd14
312831risperiDONE 2 MG Oral TabletPSN43aa2a4f-1123-4f86-800b-9218882f7bcd14
312832risperiDONE 3 MG Oral TabletPSN43aa2a4f-1123-4f86-800b-9218882f7bcd14
314211risperiDONE 4 MG Oral TabletPSN43aa2a4f-1123-4f86-800b-9218882f7bcd14
312828risperidone 0.25 MG Oral TabletSCD43aa2a4f-1123-4f86-800b-9218882f7bcd14
312829risperidone 0.5 MG Oral TabletSCD43aa2a4f-1123-4f86-800b-9218882f7bcd14
312830risperidone 1 MG Oral TabletSCD43aa2a4f-1123-4f86-800b-9218882f7bcd14
312831risperidone 2 MG Oral TabletSCD43aa2a4f-1123-4f86-800b-9218882f7bcd14
312832risperidone 3 MG Oral TabletSCD43aa2a4f-1123-4f86-800b-9218882f7bcd14
314211risperidone 4 MG Oral TabletSCD43aa2a4f-1123-4f86-800b-9218882f7bcd14
312828risperiDONE 0.25 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312829risperiDONE 0.5 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312830risperiDONE 1 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312831risperiDONE 2 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312832risperiDONE 3 MG Oral TabletPSN7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312828risperidone 0.25 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312829risperidone 0.5 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312830risperidone 1 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312831risperidone 2 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312832risperidone 3 MG Oral TabletSCD7bbc37f1-6d6a-4021-8976-1f103ce1cfbd13
312829risperiDONE 0.5 MG Oral TabletPSN26ccac3b-9fee-e18c-e063-6394a90ab6811
312829risperidone 0.5 MG Oral TabletSCD26ccac3b-9fee-e18c-e063-6394a90ab6811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-340-064354703400660 TABLET in 1 BOTTLE (43547-340-06) 60 tablet2014-06-010000-00-00NoNoCurrent
43547-340-5043547034050500 TABLET in 1 BOTTLE (43547-340-50) 500 tablet2014-06-010000-00-00NoNoCurrent