Home NDC 0378-0633 ILOPERIDONE
Product NDC 0378-0633
11-digit product format 003780633
Labeler code 0378
Product ID 0378-0633_30392c6b-2f42-6e82-e063-6394a90a0c88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iloperidone
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA207231
Marketing category ANDA
Marketing start 2017-03-20
Substance ILOPERIDONE
Active strength 6 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 42 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207231-001 ILOPERIDONE ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 A207231-002 ILOPERIDONE ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 A207231-003 ILOPERIDONE ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 A207231-004 ILOPERIDONE ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 A207231-005 ILOPERIDONE ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 A207231-006 ILOPERIDONE ILOPERIDONE 10MG TABLET / ORAL 2016-11-28 A207231-007 ILOPERIDONE ILOPERIDONE 12MG TABLET / ORAL 2016-11-28
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 8 · 294 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 2026-08-18 06:07:40 2026-07 A207231-001 ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207231-002 ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207231-003 ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207231-004 ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207231-005 ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207231-006 ILOPERIDONE 10MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207231-007 ILOPERIDONE 12MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207231-001 ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207231-002 ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207231-003 ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207231-004 ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207231-005 ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207231-006 ILOPERIDONE 10MG TABLET / ORAL 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207231-007 ILOPERIDONE 12MG TABLET / ORAL 2016-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-001 ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-002 ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-003 ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-004 ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-005 ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-006 ILOPERIDONE 10MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207231-007 ILOPERIDONE 12MG TABLET / ORAL 2016-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207231-001 ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207231-002 ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207231-003 ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207231-004 ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207231-005 ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207231-006 ILOPERIDONE 10MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207231-007 ILOPERIDONE 12MG TABLET / ORAL 2016-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-001 ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-002 ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-003 ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-004 ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-005 ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-006 ILOPERIDONE 10MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207231-007 ILOPERIDONE 12MG TABLET / ORAL 2016-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207231-001 ILOPERIDONE 1MG TABLET / ORAL 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207231-002 ILOPERIDONE 2MG TABLET / ORAL 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207231-003 ILOPERIDONE 4MG TABLET / ORAL 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207231-004 ILOPERIDONE 6MG TABLET / ORAL 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207231-005 ILOPERIDONE 8MG TABLET / ORAL 2016-11-28 b8a1b40f171c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ILOPERIDONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ILOPERIDONE 6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VPO7KJ050N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848722 Internal RxNorm lookup 848728 Internal RxNorm lookup 848732 Internal RxNorm lookup 848736 Internal RxNorm lookup 848740 Internal RxNorm lookup 848744 Internal RxNorm lookup 848748 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 0378-0633-01 ILOPERIDONE 100 in 1 BOTTLE TABLET 100 10 0378-0633-88 ILOPERIDONE 10 in 1 CARTON TABLET 10 10 0378-0633-88 ILOPERIDONE 10 in 1 BLISTER PACK TABLET 10 10 0378-0633-91 ILOPERIDONE 60 in 1 BOTTLE TABLET 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0633 ILOPERIDONE TABLET [MYLAN PHARMACEUTICALS INC.] 10 Current NDC, Legacy NDC, 4 package rows 20250316_eeb0fcfd-e4e8-4fb1-9635-901dc9446235.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 0378-0633-01 00378063301 100 TABLET in 1 BOTTLE (0378-0633-01) 100 tablet 2017-03-20 0000-00-00 No No Current 0378-0633-88 00378063388 10 BLISTER PACK in 1 CARTON (0378-0633-88) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2017-03-20 0000-00-00 No No Current 0378-0633-91 00378063391 60 TABLET in 1 BOTTLE (0378-0633-91) 60 tablet 2017-03-20 0000-00-00 No No Current