risperidone

Product NDC
65841-667
11-digit product format
658410667
Labeler code
65841
Product ID
65841-667_d39bd21c-64bb-4eff-8713-5a5ed9b98c9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078040
Marketing category
ANDA
Marketing start
2008-11-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078040-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-10-16
A078040-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-10-16
A078040-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-10-16
A078040-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-10-16
A078040-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-10-16
A078040-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A078040-001AB
A078040-002AB
A078040-003AB
A078040-004AB
A078040-005AB
A078040-006AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-005RISPERIDONE3MGTABLET / ORALAB2008-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-006RISPERIDONE4MGTABLET / ORALAB2008-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-003RISPERIDONE1MGTABLET / ORALAB2008-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-004RISPERIDONE2MGTABLET / ORALAB2008-10-162680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078040-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078040-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078040-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078040-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078040-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078040-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078040-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078040-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078040-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
risperidone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L6UH7ZF8HCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312828Internal RxNorm lookup
312829Internal RxNorm lookup
312830Internal RxNorm lookup
312831Internal RxNorm lookup
312832Internal RxNorm lookup
314211Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23993d21-80bf-41c4-b57d-88a620173b6bAvailable on FDA.report

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
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-667-01risperidone100 in 1 BOTTLETABLET, FILM COATED1009
65841-667-05risperidone500 in 1 BOTTLETABLET, FILM COATED5009
65841-667-06risperidone30 in 1 BOTTLETABLET, FILM COATED309
65841-667-10risperidone1000 in 1 BOTTLETABLET, FILM COATED10009
65841-667-14risperidone60 in 1 BOTTLETABLET, FILM COATED609
65841-667-16risperidone90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-667RISPERIDONE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 6 package rows20240815_23993d21-80bf-41c4-b57d-88a620173b6b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
risperidoneRISPERIDONECardinal Health 107, LLC3ce21196-4aa0-469b-8f04-6650b2c48cb52026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEMajor Pharmaceuticalsd5abd75f-7f4a-4a7d-b849-82fce88f5ff72026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
RisperidoneRISPERIDONEAmerican Health Packagingf11dae15-b057-4258-9229-3819d0c980fe2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEZydus Pharmaceuticals USA Inc.713b5ac7-53d6-4139-8599-3028f789de4b2025-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040
risperidoneRISPERIDONEZydus Lifesciences Limited23993d21-80bf-41c4-b57d-88a620173b6b2024-08-12Exact identifier
application applno (ANDA): 078040
application number: ANDA078040
ndc (product): 65841-667
risperidoneRISPERIDONEProficient Rx LPb611fe52-1787-47e6-8a6b-1999a4e4f22c2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078040
application number: ANDA078040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN23993d21-80bf-41c4-b57d-88a620173b6b9
312829risperiDONE 0.5 MG Oral TabletPSN23993d21-80bf-41c4-b57d-88a620173b6b9
312830risperiDONE 1 MG Oral TabletPSN23993d21-80bf-41c4-b57d-88a620173b6b9
312831risperiDONE 2 MG Oral TabletPSN23993d21-80bf-41c4-b57d-88a620173b6b9
312832risperiDONE 3 MG Oral TabletPSN23993d21-80bf-41c4-b57d-88a620173b6b9
314211risperiDONE 4 MG Oral TabletPSN23993d21-80bf-41c4-b57d-88a620173b6b9
312828risperidone 0.25 MG Oral TabletSCD23993d21-80bf-41c4-b57d-88a620173b6b9
312829risperidone 0.5 MG Oral TabletSCD23993d21-80bf-41c4-b57d-88a620173b6b9
312830risperidone 1 MG Oral TabletSCD23993d21-80bf-41c4-b57d-88a620173b6b9
312831risperidone 2 MG Oral TabletSCD23993d21-80bf-41c4-b57d-88a620173b6b9
312832risperidone 3 MG Oral TabletSCD23993d21-80bf-41c4-b57d-88a620173b6b9
314211risperidone 4 MG Oral TabletSCD23993d21-80bf-41c4-b57d-88a620173b6b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-667-0165841066701100 TABLET, FILM COATED in 1 BOTTLE (65841-667-01) 2008-11-130000-00-00NoNoCurrent
65841-667-0565841066705500 TABLET, FILM COATED in 1 BOTTLE (65841-667-05) 2008-11-130000-00-00NoNoCurrent
65841-667-066584106670630 TABLET, FILM COATED in 1 BOTTLE (65841-667-06) 2008-11-130000-00-00NoNoCurrent
65841-667-10658410667101000 TABLET, FILM COATED in 1 BOTTLE (65841-667-10) 2008-11-130000-00-00NoNoCurrent
65841-667-146584106671460 TABLET, FILM COATED in 1 BOTTLE (65841-667-14) 2008-11-130000-00-00NoNoCurrent
65841-667-166584106671690 TABLET, FILM COATED in 1 BOTTLE (65841-667-16) 2008-11-130000-00-00NoNoCurrent