RISPERIDONE

Product NDC
43063-908
11-digit product format
430630908
Labeler code
43063
Product ID
43063-908_32d6d5a1-fa47-3097-e063-6294a90ac4e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-03-28
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
A201003-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2011-08-24
A201003-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2011-08-24
A201003-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2011-08-24
A201003-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2011-08-24
A201003-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2011-08-24
A201003-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2011-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201003-001AB
A201003-002AB
A201003-003AB
A201003-004AB
A201003-005AB
A201003-006AB

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 UTC2026-02A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-005RISPERIDONE3MGTABLET / ORALAB2011-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-006RISPERIDONE4MGTABLET / ORALAB2011-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-001RISPERIDONE0.25MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-002RISPERIDONE0.5MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-003RISPERIDONE1MGTABLET / ORALAB2011-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-004RISPERIDONE2MGTABLET / ORALAB2011-08-242680178bc6a6…

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 UTC2026-02A201003-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201003-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201003-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201003-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201003-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201003-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201003-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201003-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201003-004AB12680178bc6a6…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312830Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
be388943-fe0c-4c82-ac8e-3df9f77b2891Available 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
43063-908-07RISPERIDONE7 in 1 BOTTLE, PLASTICTABLET720
43063-908-30RISPERIDONE30 in 1 BOTTLE, PLASTICTABLET3020
43063-908-60RISPERIDONE60 in 1 BOTTLE, PLASTICTABLET6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-908-07EA - Each43063-90871fb9421-6b6f-4ed5-83c5-16c2efb5966112022-10-06
43063-908-30EA - Each43063-908eeb732f7-e1ce-4933-9e06-4b767a3036af12019-01-24
43063-908-60EA - Each43063-90818302413-0d72-4d3a-82bb-121c6e1efc2c12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-908RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 3 package rows20250417_be388943-fe0c-4c82-ac8e-3df9f77b2891.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RISPERIDONERISPERIDONECoupler LLC5643c32b-310e-4888-e063-6394a90ab62f2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee495f20-c668-4d8f-9684-1029a4f232db2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.03d3b52d-3a7d-4595-84c9-332da6ca91712026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONECoupler LLC52bb35ac-1f7d-bfbe-e063-6294a90aa2b92026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEA-S Medication Solutionsa6767972-2d3f-482b-80bd-ac93e28fdd052026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.bdb08381-dbfc-442e-8d3c-22d3a0f2f6c52026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.2776a647-678d-465c-9db3-4a9459ce779e2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.5d9519af-5a5e-47ce-8a0f-9b9cfac00e192026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee7d6779-7421-4761-99d2-ccbfde9385a82026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEREMEDYREPACK INC.101b2d4d-4740-4225-94bc-aecc05d82c6b2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEAjanta Pharma USA Inc.095630bd-a77e-434e-94ee-f13da445d8f22025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.be388943-fe0c-4c82-ac8e-3df9f77b28912025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
ndc (product): 43063-908
RisperidoneRISPERIDONEDirect_Rx0b784f21-fc02-6542-e063-6294a90a285e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONENuCare Pharmaceuticals,Inc.79648a52-1364-c25b-e053-2a91aa0a8ea42024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepack420cfeef-0061-43b9-9491-dbd6ad866e552024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepackaab773b2-a605-4cf8-a301-57e390fe67a62024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepack2f83d3e9-04ab-4b24-ad1f-7ed2e784298a2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEBryant Ranch Prepacke35be034-6275-41fb-bec4-9ae4514587012024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEA-S Medication Solutions523d4f99-1d6f-413f-9d6e-2ca430aaac142024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003
RISPERIDONERISPERIDONEAphena Pharma Solutions - Tennessee, LLCbda104ac-1eea-4a1a-836a-24bcc034b90f2022-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201003
application number: ANDA201003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSNbe388943-fe0c-4c82-ac8e-3df9f77b289120
312830risperidone 1 MG Oral TabletSCDbe388943-fe0c-4c82-ac8e-3df9f77b289120

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-908-07430630908077 TABLET in 1 BOTTLE, PLASTIC (43063-908-07) 7 tablet2022-08-110000-00-00NoNoCurrent
43063-908-304306309083030 TABLET in 1 BOTTLE, PLASTIC (43063-908-30) 30 tablet2018-11-270000-00-00NoNoCurrent
43063-908-604306309086060 TABLET in 1 BOTTLE, PLASTIC (43063-908-60) 60 tablet2018-11-270000-00-00NoNoCurrent