Risperidone

Product NDC
84677-006
Requested package NDC
84677-006-05
11-digit product format
846770006
Labeler code
84677
Product ID
84677-006_44846029-352f-2325-e063-6394a90a38a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078828
Marketing category
ANDA
Marketing start
2009-03-23
Substance
RISPERIDONE
Active strength
3 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078828-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2009-03-23
A078828-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2009-03-23
A078828-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2009-03-23
A078828-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2009-03-23
A078828-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2009-03-23
A078828-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2009-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078828-001AB
A078828-002AB
A078828-003AB
A078828-004AB
A078828-005AB
A078828-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078828-001RISPERIDONE0.25MGTABLET / ORALAB2009-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A078828-002RISPERIDONE0.5MGTABLET / ORALAB2009-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A078828-003RISPERIDONE1MGTABLET / ORALAB2009-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A078828-004RISPERIDONE2MGTABLET / ORALAB2009-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A078828-005RISPERIDONE3MGTABLET / ORALAB2009-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A078828-006RISPERIDONE4MGTABLET / ORALAB2009-03-2384e616aacf4f…
2026-08-18 06:07:402026-07A078828-001RISPERIDONE0.25MGTABLET / ORALAB2009-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-002RISPERIDONE0.5MGTABLET / ORALAB2009-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-003RISPERIDONE1MGTABLET / ORALAB2009-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-004RISPERIDONE2MGTABLET / ORALAB2009-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-005RISPERIDONE3MGTABLET / ORALAB2009-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-006RISPERIDONE4MGTABLET / ORALAB2009-03-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078828-001RISPERIDONE0.25MGTABLET / ORALAB2009-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-002RISPERIDONE0.5MGTABLET / ORALAB2009-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-003RISPERIDONE1MGTABLET / ORALAB2009-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-004RISPERIDONE2MGTABLET / ORALAB2009-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-005RISPERIDONE3MGTABLET / ORALAB2009-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-006RISPERIDONE4MGTABLET / ORALAB2009-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-001RISPERIDONE0.25MGTABLET / ORALAB2009-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-002RISPERIDONE0.5MGTABLET / ORALAB2009-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-003RISPERIDONE1MGTABLET / ORALAB2009-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-004RISPERIDONE2MGTABLET / ORALAB2009-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-005RISPERIDONE3MGTABLET / ORALAB2009-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-006RISPERIDONE4MGTABLET / ORALAB2009-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078828-001RISPERIDONE0.25MGTABLET / ORAL2009-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078828-002RISPERIDONE0.5MGTABLET / ORAL2009-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078828-003RISPERIDONE1MGTABLET / ORAL2009-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078828-004RISPERIDONE2MGTABLET / ORAL2009-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078828-005RISPERIDONE3MGTABLET / ORAL2009-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078828-006RISPERIDONE4MGTABLET / ORAL2009-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078828-001RISPERIDONE0.25MGTABLET / ORAL2009-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078828-002RISPERIDONE0.5MGTABLET / ORAL2009-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078828-003RISPERIDONE1MGTABLET / ORAL2009-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078828-004RISPERIDONE2MGTABLET / ORAL2009-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078828-005RISPERIDONE3MGTABLET / ORAL2009-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078828-006RISPERIDONE4MGTABLET / ORAL2009-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078828-001RISPERIDONE0.25MGTABLET / ORAL2009-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078828-002RISPERIDONE0.5MGTABLET / ORAL2009-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078828-003RISPERIDONE1MGTABLET / ORAL2009-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078828-004RISPERIDONE2MGTABLET / ORAL2009-03-23b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078828-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078828-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078828-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078828-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078828-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A078828-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A078828-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078828-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078828-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078828-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078828-006AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078828-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078828-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078828-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078828-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078828-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078828-006AB1a50c72e98297…

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
RISPERIDONE3 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
448467a3-44ef-c87b-e063-6294a90a5ec9Available 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
84677-006-05Risperidone500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84677-006-05EA - Each84677-0069e9dae90-4b62-410b-ae3b-424a3216044212026-01-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEGolden State Medical Supply, Inc.448467a3-44ef-c87b-e063-6294a90a5ec92025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078828
application number: ANDA078828
ndc (package): 84677-006-05
ndc (product): 84677-006
ndc11 (package): 84677000605
RisperidoneRISPERIDONEJubilant Cadista Pharmacuticals Inc.39d41b28-93eb-446b-9652-7432858ccbab2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078828
application number: ANDA078828

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312829risperiDONE 0.5 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312830risperiDONE 1 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312831risperiDONE 2 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312832risperiDONE 3 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
314211risperiDONE 4 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312828risperidone 0.25 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312829risperidone 0.5 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312830risperidone 1 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312831risperidone 2 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312832risperidone 3 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
314211risperidone 4 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84677-006-0584677000605500 TABLET in 1 BOTTLE (84677-006-05) 500 tablet2025-09-26NoNoCurrent