RISPERDAL

Product NDC
50458-302
11-digit product format
504580302
Labeler code
50458
Product ID
50458-302_b7f7983b-0d54-4910-9399-5b83d218bd74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA020272
Marketing category
NDA
Marketing start
1993-12-29
Substance
RISPERIDONE
Active strength
.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50458-30250458-302-01DDiscontinued by firm2026-10-28
excluded packagepackage50458-30250458-302-50DDiscontinued by firm2026-10-28

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020272-001RISPERDALRISPERIDONE1MGTABLET / ORALABRLD, RS1993-12-29
N020272-002RISPERDALRISPERIDONE2MGTABLET / ORALABRLD1993-12-29
N020272-003RISPERDALRISPERIDONE3MGTABLET / ORALABRLD1993-12-29
N020272-004RISPERDALRISPERIDONE4MGTABLET / ORALABRLD1993-12-29
N020272-005RISPERDALRISPERIDONE5MGTABLET / ORAL1993-12-29
N020272-007RISPERDALRISPERIDONE0.5MGTABLET / ORALABRLD1999-01-27
N020272-008RISPERDALRISPERIDONE0.25MGTABLET / ORALABRLD1999-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020272-001AB
N020272-002AB
N020272-003AB
N020272-004AB
N020272-007AB
N020272-008AB

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 8 · 308 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29c2088c7a36db…
2026-10-15 13:18:302026-09N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27c2088c7a36db…
2026-10-15 13:18:302026-09N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10c2088c7a36db…
2026-09-14 22:38:342026-08N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-1084e616aacf4f…
2026-08-18 06:07:402026-07N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-005RISPERDAL5MGTABLET / ORAL1993-12-296a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020272-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-007AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020272-008AB1c2088c7a36db…
2026-09-14 22:38:342026-08N020272-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-007AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-008AB184e616aacf4f…
2026-08-18 06:07:402026-07N020272-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020272-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020272-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-004AB1fd3edfee7708…

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
RISPERDAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE.5 mg/1

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-302-01RISPERDAL10 in 1 BLISTER PACKTABLET1042
50458-302-01RISPERDAL10 in 1 BOX, UNIT-DOSETABLET1042
50458-302-06RISPERDAL60 in 1 BOTTLETABLET6042
50458-302-50RISPERDAL500 in 1 BOTTLETABLET50042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-302-01EA - Each50458-302113d020c-b7c6-4a6d-be9e-9d1282a3504112012-07-24
50458-302-06EA - Each50458-302b468552c-3ff5-4043-8073-a71127dfff0712012-07-24
50458-302-50EA - Each50458-30257eb1177-6c84-4971-af65-5a5c7b85df5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
risperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
risperidoneACTIVE MOIETYL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
aspartameINACTIVE INGREDIENTZ0H242BBR1RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ERISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ferric oxide redINACTIVE INGREDIENT1K09F3G675RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
gelatinINACTIVE INGREDIENT2G86QN327LRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
glycineINACTIVE INGREDIENTTE7660XO1CRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WORISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
magnesium stearateINACTIVE INGREDIENT70097M6I30RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
mannitolINACTIVE INGREDIENT3OWL53L36ARISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
peppermint oilINACTIVE INGREDIENTAV092KU4JHRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
propylene glycolINACTIVE INGREDIENT6DC9Q167V3RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sodium hydroxideINACTIVE INGREDIENT55X04QC32IRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
starch, cornINACTIVE INGREDIENTO8232NY3SJRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
talcINACTIVE INGREDIENT7SEV7J4R1URISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
tartaric acidINACTIVE INGREDIENTW4888I119HRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
waterINACTIVE INGREDIENT059QF0KO0RRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
xanthan gumINACTIVE INGREDIENTTTV12P4NEERISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
risperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
risperidoneACTIVE MOIETYL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKRISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
ferric oxide redINACTIVE INGREDIENT1K09F3G675RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
hypromellosesINACTIVE INGREDIENT3NXW29V3WORISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
magnesium stearateINACTIVE INGREDIENT70097M6I30RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
propylene glycolINACTIVE INGREDIENT6DC9Q167V3RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4RISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JRISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
starch, cornINACTIVE INGREDIENTO8232NY3SJRISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
talcINACTIVE INGREDIENT7SEV7J4R1URISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRISPERDAL (RISPERIDONE) TABLET [PD-RX PHARMACEUTICALS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-302RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]40Current NDC, Legacy NDC, 4 package rows20250228_7e117c7e-02fc-4343-92a1-230061dfc5e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-302-015045803020110 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-302-01) > 10 TABLET in 1 BLISTER PACK10 blister pack1993-12-290000-00-00NoNoCurrent
50458-302-065045803020660 TABLET in 1 BOTTLE (50458-302-06) 60 tablet1993-12-290000-00-00NoNoCurrent
50458-302-5050458030250500 in 1 BOTTLEHistorical