Home NDC 70518-3760-0 Risperidone
Product NDC 70518-3760
Requested package NDC 70518-3760-0
11-digit product format 705183760
Labeler code 70518
Product ID 70518-3760_4f8356fa-4c24-9f88-e063-6294a90a09d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risperidone
Dosage form SOLUTION
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA020588
Marketing category NDA
Marketing start 2023-06-12
Substance RISPERIDONE
Active strength 1 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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 · 43 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 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020588-001 RISPERDAL 1MG/ML SOLUTION / ORAL AA RLD, RS 1996-06-10 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199387 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 70518-3760-0 Risperidone 10 in 1 BOX SOLUTION 10 5 70518-3760-1 Risperidone 2 mL in 1 CUP, UNIT-DOSE SOLUTION 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3760 RISPERIDONE SOLUTION [REMEDYREPACK INC.] 2 Current NDC, 2 package rows 20240331_ab1cf6fd-9932-47fc-8736-476cc53a13fa.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 Pharmaceuticals, Inc. 701e1cd8-2868-4d29-85a9-a2212c88165f 2026-08-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020588 application number: NDA020588 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 ndc (package): 70518-3760-0 ndc (product): 70518-3760 ndc11 (package): 70518376000
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-3760-0 70518376000 10 CUP, UNIT-DOSE in 1 BOX (70518-3760-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3760-1) 2023-06-12 No No Current