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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51672-4178DDiscontinued by firm2026-08-17
excluded packagepackage51672-417851672-4178-4DDiscontinued by firm2026-08-17

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct51672-4178DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-417851672-4178-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207098-001ILOPERIDONEILOPERIDONE1MGTABLET / ORAL2019-07-22
A207098-002ILOPERIDONEILOPERIDONE2MGTABLET / ORAL2019-07-22
A207098-003ILOPERIDONEILOPERIDONE4MGTABLET / ORAL2019-07-22
A207098-004ILOPERIDONEILOPERIDONE6MGTABLET / ORAL2019-07-22
A207098-005ILOPERIDONEILOPERIDONE8MGTABLET / ORAL2019-07-22
A207098-006ILOPERIDONEILOPERIDONE10MGTABLET / ORAL2019-07-22
A207098-007ILOPERIDONEILOPERIDONE12MGTABLET / ORAL2019-07-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207098-001ILOPERIDONE1MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207098-002ILOPERIDONE2MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207098-003ILOPERIDONE4MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207098-004ILOPERIDONE6MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207098-005ILOPERIDONE8MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207098-006ILOPERIDONE10MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207098-007ILOPERIDONE12MGTABLET / ORAL2019-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207098-001ILOPERIDONE1MGTABLET / ORAL2019-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207098-002ILOPERIDONE2MGTABLET / ORAL2019-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207098-003ILOPERIDONE4MGTABLET / ORAL2019-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207098-004ILOPERIDONE6MGTABLET / ORAL2019-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207098-005ILOPERIDONE8MGTABLET / ORAL2019-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207098-006ILOPERIDONE10MGTABLET / ORAL2019-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207098-007ILOPERIDONE12MGTABLET / ORAL2019-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-001ILOPERIDONE1MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-002ILOPERIDONE2MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-003ILOPERIDONE4MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-004ILOPERIDONE6MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-005ILOPERIDONE8MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-006ILOPERIDONE10MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207098-007ILOPERIDONE12MGTABLET / ORAL2019-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207098-001ILOPERIDONE1MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207098-002ILOPERIDONE2MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207098-003ILOPERIDONE4MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207098-004ILOPERIDONE6MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207098-005ILOPERIDONE8MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207098-006ILOPERIDONE10MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207098-007ILOPERIDONE12MGTABLET / ORAL2019-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-001ILOPERIDONE1MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-002ILOPERIDONE2MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-003ILOPERIDONE4MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-004ILOPERIDONE6MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-005ILOPERIDONE8MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-006ILOPERIDONE10MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207098-007ILOPERIDONE12MGTABLET / ORAL2019-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207098-001ILOPERIDONE1MGTABLET / ORAL2019-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207098-002ILOPERIDONE2MGTABLET / ORAL2019-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207098-003ILOPERIDONE4MGTABLET / ORAL2019-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207098-004ILOPERIDONE6MGTABLET / ORAL2019-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207098-005ILOPERIDONE8MGTABLET / ORAL2019-07-22b8a1b40f171c…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4178ILOPERIDONE TABLET ILOPERIDONE KIT [-SUN PHARMACEUTICAL INDUSTRIES, INC.]4Legacy NDC20250406_6f17cc91-86b3-42e3-9bf2-935dd360c3eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4178-45167241780460 TABLET in 1 BOTTLE (51672-4178-4) 60 tablet2019-07-220000-00-00NoNoCurrent