Risperidone

Product NDC
68084-277
11-digit product format
680840277
Labeler code
68084
Product ID
68084-277_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
4 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
RISPERIDONE4 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
f11dae15-b057-4258-9229-3819d0c980feAvailable 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
68084-277-01Risperidone100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10016
68084-277-11Risperidone1 in 1 BLISTER PACKTABLET, FILM COATED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-277-01EA - Each68084-2772d621571-d650-4b96-a062-8395233112d812012-07-24
68084-277-11EA - Each68084-2773d4b1404-92d8-46af-beed-f3a7a6f2fa9712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-277RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]15Current NDC, Legacy NDC, 2 package rows20250104_f11dae15-b057-4258-9229-3819d0c980fe.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
ndc (product): 68084-277
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
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 TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312829risperiDONE 0.5 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312830risperiDONE 1 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312831risperiDONE 2 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312832risperiDONE 3 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
314211risperiDONE 4 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312828risperidone 0.25 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312829risperidone 0.5 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312830risperidone 1 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312831risperidone 2 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312832risperidone 3 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
314211risperidone 4 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-277-0168084027701100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-277-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-277-11) 100 blister pack2008-12-020000-00-00NoNoCurrent
68084-277-11680840277111 in 1 BLISTER PACKHistorical