Home NDC 17856-0380 Risperidone
Product NDC 17856-0380
11-digit product format 178560380
Labeler code 17856
Product ID 17856-0380_09287282-1b8e-4c4d-a32f-193630499b8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form SOLUTION
Route ORAL
Labeler Atlantic Biologicals Corps
Application ANDA091384
Marketing category ANDA
Marketing start 2011-05-31
Marketing end 0000-00-00
Substance RISPERIDONE
Active strength 1 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091384-001 RISPERIDONE 1MG/ML SOLUTION / ORAL AA 2011-05-25 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A091384-001 AA 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091384-001 AA 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091384-001 AA 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091384-001 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0380-1 Risperidone 1 mL in 1 SYRINGE SOLUTION 1 2 17856-0380-2 Risperidone 2 mL in 1 SYRINGE SOLUTION 2 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0380 RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 Legacy NDC, 2 package rows 20120504_dae5ec58-85c1-4503-a6b8-56696dd1e6fc.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Risperidone RISPERIDONE Amneal Pharmaceuticals LLC bc55f60a-8121-44bb-bdfc-1d311879ba4f 2025-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091384 application number: ANDA091384
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 17856-0380-1 17856038001 1 mL in 1 SYRINGE 1 ml Historical 17856-0380-2 17856038002 2 mL in 1 SYRINGE 2 ml Historical