Home NDC 65162-673 Risperidone
Product NDC 65162-673
11-digit product format 651620673
Labeler code 65162
Product ID 65162-673_bdd3de74-828c-406b-a179-343b4c24d1d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA091384
Marketing category ANDA
Marketing start 2011-05-31
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 A091384-001 RISPERIDONE RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091384-001 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 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 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 2026-12-31 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 65162-673-84 Risperidone 30 mL in 1 BOTTLE SOLUTION 30 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-673 RISPERIDONE SOLUTION [AMNEAL PHARMACEUTICALS LLC] 22 Current NDC, Legacy NDC, 1 package rows 20250223_bc55f60a-8121-44bb-bdfc-1d311879ba4f.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 65162-673-84 65162067384 30 mL in 1 BOTTLE (65162-673-84) 30 ml 2011-05-31 0000-00-00 No No Current