Home NDC 50458-596 Risperidone
Product NDC 50458-596
11-digit product format 504580596
Labeler code 50458
Product ID 50458-596_3b408b5f-285c-68a9-e063-6294a90ad609
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form SOLUTION
Route ORAL
Labeler Janssen Pharmaceutical, Inc.
Application NDA020588
Marketing category NDA
Marketing start 1996-06-10
Substance RISPERIDONE
Active strength 1 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020588-001 RISPERDAL RISPERIDONE 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020588-001 AA
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 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Risperidone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISPERIDONE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L6UH7ZF8HC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 11 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199387 Internal RxNorm lookup 312829 Internal RxNorm lookup 312830 Internal RxNorm lookup 312831 Internal RxNorm lookup 312832 Internal RxNorm lookup 314211 Internal RxNorm lookup 401953 Internal RxNorm lookup 401954 Internal RxNorm lookup 403825 Internal RxNorm lookup 616698 Internal RxNorm lookup 616705 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-596-01 Risperidone 30 mL in 1 BOTTLE SOLUTION 30 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded risperidone ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 risperidone ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 aspartame INACTIVE INGREDIENT Z0H242BBR1 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 benzoic acid INACTIVE INGREDIENT 8SKN0B0MIM RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 carbomer homopolymer type c (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 4Q93RCW27E RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 gelatin INACTIVE INGREDIENT 2G86QN327L RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 glycine INACTIVE INGREDIENT TE7660XO1C RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 mannitol INACTIVE INGREDIENT 3OWL53L36A RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 peppermint oil INACTIVE INGREDIENT AV092KU4JH RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 starch, corn INACTIVE INGREDIENT O8232NY3SJ RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 talc INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 tartaric acid INACTIVE INGREDIENT W4888I119H RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 water INACTIVE INGREDIENT 059QF0KO0R RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10 xanthan gum INACTIVE INGREDIENT TTV12P4NEE RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-596 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 32 Current NDC, Legacy NDC, 1 package rows 20250302_701e1cd8-2868-4d29-85a9-a2212c88165f.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Risperidone RISPERIDONE Janssen Pharmaceutical, Inc. 701e1cd8-2868-4d29-85a9-a2212c88165f 2026-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020588 application number: NDA020588 ndc (product): 50458-596 RISPERDAL RISPERIDONE Janssen Pharmaceuticals, Inc. 7e117c7e-02fc-4343-92a1-230061dfc5e0 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020588 application number: NDA020588 Risperidone RISPERIDONE REMEDYREPACK INC. ab1cf6fd-9932-47fc-8736-476cc53a13fa 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020588 application number: NDA020588
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50458-596-01 50458059601 30 mL in 1 BOTTLE (50458-596-01) 30 ml 1996-06-10 0000-00-00 No No Current