Home NDC 13668-038 Risperidone
Product NDC 13668-038
11-digit product format 136680038
Labeler code 13668
Product ID 13668-038_cd8bfb14-7054-4c69-b27f-8a960b5ecb5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA079088
Marketing category ANDA
Marketing start 2009-01-01
Substance RISPERIDONE
Active strength 2 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 2 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 13668-038-01 Risperidone 100 in 1 BOTTLE TABLET 100 25 13668-038-05 Risperidone 500 in 1 BOTTLE TABLET 500 25 13668-038-55 Risperidone 4200 in 1 BOTTLE TABLET 4200 25 13668-038-60 Risperidone 60 in 1 BOTTLE TABLET 60 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED] 12 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED] 12 RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC] 5 RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [H.J. HARKINS COMPANY, INC.] 3 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [H.J. HARKINS COMPANY, INC.] 3 RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [STAT RX USA LLC] 1 RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP] 1 RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 RISPERIDONE ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP] 1 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [STAT RX USA LLC] 1 RISPERIDONE ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK RISPERIDONE TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISPERIDONE TABLET [STAT RX USA LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE TABLET [STAT RX USA LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISPERIDONE TABLET [STAT RX USA LLC] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RISPERIDONE TABLET [STAT RX USA LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET [STAT RX USA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RISPERIDONE TABLET [STAT RX USA LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RISPERIDONE TABLET [STAT RX USA LLC] 1 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE TABLET [STAT RX USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISPERIDONE TABLET [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-038 RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED] 24 Current NDC, Legacy NDC, 4 package rows 20250227_a6347895-5f16-43b4-92a0-b9904ac81937.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 13668-038-01 13668003801 100 TABLET in 1 BOTTLE (13668-038-01) 100 tablet 2009-01-01 0000-00-00 No No Current 13668-038-05 13668003805 500 TABLET in 1 BOTTLE (13668-038-05) 500 tablet 2009-01-01 0000-00-00 No No Current 13668-038-55 13668003855 4200 TABLET in 1 BOTTLE (13668-038-55) 4200 tablet 2009-01-01 0000-00-00 No No Current 13668-038-60 13668003860 60 TABLET in 1 BOTTLE (13668-038-60) 60 tablet 2009-01-01 0000-00-00 No No Current 13668-038-74 13668003874 100 TABLET in 1 CARTON (13668-038-74) 100 tablet 2009-01-01 0000-00-00 No No Current