Risperidone

Product NDC
63304-949
Requested package NDC
63304-949-30
11-digit product format
633040949
Labeler code
63304
Product ID
63304-949_8c155c45-e5c8-4358-90da-8f6d193ad88b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077542
Marketing category
ANDA
Marketing start
2010-08-06
Substance
RISPERIDONE
Active strength
.5 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077542-001RISPERIDONERISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06
A077542-002RISPERIDONERISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06
A077542-003RISPERIDONERISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077542-001AB
A077542-002AB
A077542-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0684e616aacf4f…
2026-09-14 22:38:342026-08A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0684e616aacf4f…
2026-09-14 22:38:342026-08A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0684e616aacf4f…
2026-08-18 06:07:402026-07A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077542-002RISPERIDONE1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077542-003RISPERIDONE2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077542-001RISPERIDONE0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-08-06301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077542-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077542-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077542-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077542-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077542-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077542-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077542-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077542-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077542-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077542-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077542-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077542-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077542-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077542-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077542-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077542-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077542-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077542-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077542-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077542-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077542-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077542-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077542-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077542-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077542-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077542-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077542-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077542-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077542-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077542-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077542-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077542-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077542-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077542-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077542-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077542-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077542-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077542-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077542-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077542-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE.5 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
401953Internal RxNorm lookup
401954Internal RxNorm lookup
403825Internal RxNorm lookup
616698Internal RxNorm lookup
616705Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f91f551e-926f-440d-83d2-357e9d7484feAvailable 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
63304-949-05Risperidone500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50011
63304-949-11Risperidone1 in 1 POUCHTABLET, ORALLY DISINTEGRATING111
63304-949-17Risperidone10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1011
63304-949-30Risperidone30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-949RISPERIDONE TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 4 package rows20220716_f91f551e-926f-440d-83d2-357e9d7484fe.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONESun Pharmaceutical Industries, Inc.f91f551e-926f-440d-83d2-357e9d7484fe2022-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077542
application number: ANDA077542
ndc (package): 63304-949-30
ndc (product): 63304-949
ndc11 (package): 63304094930

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403825risperiDONE 0.5 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
401953risperiDONE 1 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
401954risperiDONE 2 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
616698risperiDONE 3 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
616705risperiDONE 4 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
403825risperidone 0.5 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
401953risperidone 1 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
401954risperidone 2 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
616698risperidone 3 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
616705risperidone 4 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-949-306330409493030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-30) 2010-08-060000-00-00NoNoCurrent