Home NDC 43063-254 Risperidone
Product NDC 43063-254
11-digit product format 430630254
Labeler code 43063
Product ID 43063-254_508cb485-b804-3738-e063-6294a90a87ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA079088
Marketing category ANDA
Marketing start 2009-01-01
Substance RISPERIDONE
Active strength 1 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079088-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 A079088-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 A079088-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 A079088-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 A079088-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 A079088-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 7 · 246 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 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-005 RISPERIDONE 3MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079088-006 RISPERIDONE 4MG TABLET / ORAL AB 2008-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-003 RISPERIDONE 1MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079088-004 RISPERIDONE 2MG TABLET / ORAL AB 2008-10-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
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/1
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 312830 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 43063-254-30 Risperidone 30 in 1 BOTTLE, PLASTIC TABLET 30 28 43063-254-60 Risperidone 60 in 1 BOTTLE, PLASTIC TABLET 60 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-254 RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.] 27 Current NDC, Legacy NDC, 2 package rows 20250413_e72a2768-815f-47bf-b2f9-16a93dd10684.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 · 2 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 43063-254-30 43063025430 30 TABLET in 1 BOTTLE, PLASTIC (43063-254-30) 30 tablet 2010-06-03 0000-00-00 No No Current 43063-254-60 43063025460 60 TABLET in 1 BOTTLE, PLASTIC (43063-254-60) 60 tablet 2010-06-03 0000-00-00 No No Current