Home NDC 50458-593 Risperidone
Product NDC 50458-593
11-digit product format 504580593
Labeler code 50458
Product ID 50458-593_fd12f36e-67f4-11e9-b194-e90b0199106d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form TABLET
Route ORAL
Labeler Janssen Pharmaceutical, Inc.
Application NDA020272
Marketing category NDA
Marketing start 1993-12-29
Marketing end 2020-08-31
Substance RISPERIDONE
Active strength 2 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020272-001 RISPERDAL RISPERIDONE 1MG TABLET / ORAL AB RLD, RS 1993-12-29 N020272-002 RISPERDAL RISPERIDONE 2MG TABLET / ORAL AB RLD 1993-12-29 N020272-003 RISPERDAL RISPERIDONE 3MG TABLET / ORAL AB RLD 1993-12-29 N020272-004 RISPERDAL RISPERIDONE 4MG TABLET / ORAL AB RLD 1993-12-29 N020272-005 RISPERDAL RISPERIDONE 5MG TABLET / ORAL 1993-12-29 N020272-007 RISPERDAL RISPERIDONE 0.5MG TABLET / ORAL AB RLD 1999-01-27 N020272-008 RISPERDAL RISPERIDONE 0.25MG TABLET / ORAL AB RLD 1999-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 · 287 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 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-007 RISPERDAL 0.5MG TABLET / ORAL AB RLD 1999-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020272-008 RISPERDAL 0.25MG TABLET / ORAL AB RLD 1999-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-001 RISPERDAL 1MG TABLET / ORAL AB RLD, RS 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-002 RISPERDAL 2MG TABLET / ORAL AB RLD 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-003 RISPERDAL 3MG TABLET / ORAL AB RLD 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-004 RISPERDAL 4MG TABLET / ORAL AB RLD 1993-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020272-005 RISPERDAL 5MG TABLET / ORAL 1993-12-29 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-593-10 Risperidone 10 in 1 BOX, UNIT-DOSE TABLET 10 33 50458-593-10 Risperidone 10 in 1 BLISTER PACK TABLET 10 33 50458-593-50 Risperidone 500 in 1 BOTTLE TABLET 500 33 50458-593-60 Risperidone 60 in 1 BOTTLE TABLET 60 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 50458-593 RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] 32 Legacy NDC, 4 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50458-593-10 50458059310 10 in 1 BOX, UNIT-DOSE Historical 50458-593-50 50458059350 500 in 1 BOTTLE Historical 50458-593-60 50458059360 60 in 1 BOTTLE Historical