Home NDC 83745-186 Risperidone
Product NDC 83745-186
11-digit product format 837450186
Labeler code 83745
Product ID 83745-186_38eb3e14-7f79-42c8-ac58-2c050c6295a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form SOLUTION
Route ORAL
Labeler APOZEAL PHARMACEUTICALS INC
Application ANDA078909
Marketing category ANDA
Marketing start 2025-01-31
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 A078909-001 RISPERIDONE RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078909-001 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 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078909-001 RISPERIDONE 1MG/ML SOLUTION / ORAL 2009-07-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83745-186-30 83745018630 30 mL in 1 BOTTLE (83745-186-30) 30 ml 2025-01-31 No No Current