Home NDC 50458-306 RISPERDAL CONSTA
Product NDC 50458-306
11-digit product format 504580306
Labeler code 50458
Product ID 50458-306_42dc490b-4117-142a-e063-6294a90aeb21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form KIT
Labeler Janssen Pharmaceuticals, Inc.
Application NDA021346
Marketing category NDA
Marketing start 2003-10-29
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021346-001 RISPERDAL CONSTA RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 N021346-002 RISPERDAL CONSTA RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 N021346-003 RISPERDAL CONSTA RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 N021346-004 RISPERDAL CONSTA RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 2026-09-14 22:38:34 2026-08 N021346-001 RISPERDAL CONSTA 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021346-003 RISPERDAL CONSTA 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021346-001 RISPERDAL CONSTA 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021346-003 RISPERDAL CONSTA 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021346-001 RISPERDAL CONSTA 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021346-003 RISPERDAL CONSTA 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021346-001 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6667061 2020-05-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6667061*PED 2020-11-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6667061 2020-05-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6667061*PED 2020-11-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6667061 2020-05-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6667061*PED 2020-11-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-004 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-004 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-004 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021346-001 6667061 2020-05-25 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-001 6667061*PED 2020-11-25 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-002 6667061 2020-05-25 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-002 6667061*PED 2020-11-25 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-003 6667061 2020-05-25 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-003 6667061*PED 2020-11-25 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021346-001 6667061 2020-05-25 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-001 6667061*PED 2020-11-25 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-002 6667061 2020-05-25 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-002 6667061*PED 2020-11-25 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-003 6667061 2020-05-25 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-003 6667061*PED 2020-11-25 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021346-001 6194006*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6379703*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6596316*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6667061 2020-05-25 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6667061*PED 2020-11-25 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6194006*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6379703*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6596316*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6667061 2020-05-25 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6667061*PED 2020-11-25 Pediatric extension 3f01610625f2…
Additional Listing Data#
Finished product Yes
Brand name base RISPERDAL CONSTA
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402010 Internal RxNorm lookup 402011 Internal RxNorm lookup 402012 Internal RxNorm lookup 706822 Internal RxNorm lookup 706825 Internal RxNorm lookup 706827 Internal RxNorm lookup 706829 Internal RxNorm lookup 706831 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 50458-306-11 RISPERDAL CONSTA 1 in 1 BOX KIT 1 38
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded risperidone ACTIVE INGREDIENT L6UH7ZF8HC RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 risperidone ACTIVE MOIETY L6UH7ZF8HC RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 sodium chloride INACTIVE INGREDIENT 451W47IQ8X RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 sodium phosphate, dibasic, heptahydrate INACTIVE INGREDIENT 70WT22SF4B RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15 water INACTIVE INGREDIENT 059QF0KO0R RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-306 RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.] 37 Current NDC, Legacy NDC, 1 package rows 20250417_bb34ee82-d2c2-43b8-ba21-2825c0954691.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 · 1 matching rows.
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 50458-306-11 50458030611 1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 SYRINGE (50458-306-01) * 2 mL in 1 VIAL 1 kit 2003-10-29 0000-00-00 No No Current