Home NDC 51672-4178 Iloperidone
Product NDC 51672-4178
11-digit product format 516724178
Labeler code 51672
Product ID 51672-4178_6787555e-8a11-481c-b05c-179b0aedcf5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iloperidone
Dosage form TABLET
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA207098
Marketing category ANDA
Marketing start 2019-07-22
Marketing end 0000-00-00
Substance ILOPERIDONE
Active strength 1 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 51672-4178 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-4178 51672-4178-4 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A207098-001 ILOPERIDONE ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 A207098-002 ILOPERIDONE ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 A207098-003 ILOPERIDONE ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 A207098-004 ILOPERIDONE ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 A207098-005 ILOPERIDONE ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 A207098-006 ILOPERIDONE ILOPERIDONE 10MG TABLET / ORAL 2019-07-22 A207098-007 ILOPERIDONE ILOPERIDONE 12MG TABLET / ORAL 2019-07-22
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 · 287 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 A207098-001 ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207098-002 ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207098-003 ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207098-004 ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207098-005 ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207098-006 ILOPERIDONE 10MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207098-007 ILOPERIDONE 12MG TABLET / ORAL 2019-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207098-001 ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207098-002 ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207098-003 ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207098-004 ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207098-005 ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207098-006 ILOPERIDONE 10MG TABLET / ORAL 2019-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207098-007 ILOPERIDONE 12MG TABLET / ORAL 2019-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-001 ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-002 ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-003 ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-004 ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-005 ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-006 ILOPERIDONE 10MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207098-007 ILOPERIDONE 12MG TABLET / ORAL 2019-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207098-001 ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207098-002 ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207098-003 ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207098-004 ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207098-005 ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207098-006 ILOPERIDONE 10MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207098-007 ILOPERIDONE 12MG TABLET / ORAL 2019-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-001 ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-002 ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-003 ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-004 ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-005 ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-006 ILOPERIDONE 10MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207098-007 ILOPERIDONE 12MG TABLET / ORAL 2019-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207098-001 ILOPERIDONE 1MG TABLET / ORAL 2019-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207098-002 ILOPERIDONE 2MG TABLET / ORAL 2019-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207098-003 ILOPERIDONE 4MG TABLET / ORAL 2019-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207098-004 ILOPERIDONE 6MG TABLET / ORAL 2019-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207098-005 ILOPERIDONE 8MG TABLET / ORAL 2019-07-22 b8a1b40f171c…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4178 ILOPERIDONE TABLET ILOPERIDONE KIT [-SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Legacy NDC 20250406_6f17cc91-86b3-42e3-9bf2-935dd360c3eb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4178-4 51672417804 60 TABLET in 1 BOTTLE (51672-4178-4) 60 tablet 2019-07-22 0000-00-00 No No Current