Home NDC 62135-604-60 Risperidone
Product NDC 62135-604
Requested package NDC 62135-604-60
11-digit product format 621350604
Labeler code 62135
Product ID 62135-604_151f66f3-99b5-6d4d-e063-6394a90a1648
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA077543
Marketing category ANDA
Marketing start 2011-05-18
Substance RISPERIDONE
Active strength 3 mg/1
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 43 .
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 A077543-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 A077543-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 A077543-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 A077543-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 A077543-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 A077543-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18
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 · 258 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 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISPERIDONE 3 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312828 Internal RxNorm lookup 312829 Internal RxNorm lookup 312830 Internal RxNorm lookup 312831 Internal RxNorm lookup 312832 Internal RxNorm lookup 314211 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 62135-604-60 Risperidone 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-604 RISPERIDONE TABLET, FILM COATED [CHARTWELL RX, LLC] 3 Current NDC, 1 package rows 20240403_12a479c4-a84a-4308-b89f-be0315826fd5.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 Marketing start Sample Exclude flag Status 62135-604-60 62135060460 60 TABLET, FILM COATED in 1 BOTTLE (62135-604-60) 2023-12-29 No No Current