Home NDC 65862-167-01 RISPERIDONE
Product NDC 65862-167
Requested package NDC 65862-167-01
11-digit product format 658620167
Labeler code 65862
Product ID 65862-167_95217dea-1f5b-4645-b55f-09a5d0e6960e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RISPERIDONE
Dosage form SOLUTION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078452
Marketing category ANDA
Marketing start 2019-03-25
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 44 .
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 A078452-001 RISPERIDONE RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078452-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078452-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2009-09-04 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 65862-167-01 RISPERIDONE 30 mL in 1 BOTTLE SOLUTION 30 23 65862-167-01 RISPERIDONE 1 in 1 CARTON SOLUTION 1 23 65862-167-30 RISPERIDONE 1 in 1 CARTON SOLUTION 1 23 65862-167-30 RISPERIDONE 30 mL in 1 BOTTLE, GLASS SOLUTION 30 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-167 RISPERIDONE SOLUTION [AUROBINDO PHARMA LIMITED] 23 Current NDC, Legacy NDC, 4 package rows 20250308_c4582bdf-5eda-438c-98b4-0517500501e8.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 65862-167-01 65862016701 1 BOTTLE in 1 CARTON (65862-167-01) / 30 mL in 1 BOTTLE 1 bottle 2019-03-25 0000-00-00 No No Current