FDA.reportPublic FDA data

FANAPT

Product NDC
43068-114
11-digit product format
430680114
Labeler code
43068
Product ID
43068-114_2609a5b3-d7ec-48a9-a32b-54a9b207f9aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ILOPERIDONE
Dosage form
KIT
Route
ORAL
Labeler
Vanda Pharmaceuticals Inc.
Application
NDA022192
Marketing category
NDA
Marketing start
2025-05-01
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 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
N022192-001FANAPTILOPERIDONE1MGTABLET / ORALRLD, RS2009-05-06
N022192-002FANAPTILOPERIDONE2MGTABLET / ORALRLD2009-05-06
N022192-003FANAPTILOPERIDONE4MGTABLET / ORALRLD2009-05-06
N022192-004FANAPTILOPERIDONE6MGTABLET / ORALRLD2009-05-06
N022192-005FANAPTILOPERIDONE8MGTABLET / ORALRLD2009-05-06
N022192-006FANAPTILOPERIDONE10MGTABLET / ORALRLD2009-05-06
N022192-007FANAPTILOPERIDONE12MGTABLET / ORALRLD2009-05-06

Orange Book patents#

Current patent rows page 1 of 2 · 98 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022192-00185866102027-11-02U-16252015-01-08
N022192-001105704532028-03-28U-45622026-07-09
N022192-001105704532028-03-28U-45632026-07-09
N022192-00191571212030-04-05U-16742015-10-13
N022192-001105632592030-07-24U-45622026-07-09
N022192-001105632592030-07-24U-45632026-07-09
N022192-00186527762030-08-31U-16852015-04-30
N022192-001126068692030-09-22U-45042026-05-21
N022192-001126068692030-09-22U-45052026-05-21
N022192-00189996382030-10-28U-16742015-04-07
N022192-00190742552030-12-17U-16742015-07-28
N022192-00190727422031-01-16U-16742015-07-28
N022192-00190742562031-02-10U-16742015-07-28
N022192-00190742542031-12-28U-16742015-07-28
N022192-00285866102027-11-02U-16252015-01-08
N022192-002105704532028-03-28U-45622026-07-09
N022192-002105704532028-03-28U-45632026-07-09
N022192-00291571212030-04-05U-16742015-10-13
N022192-002105632592030-07-24U-45622026-07-09
N022192-002105632592030-07-24U-45632026-07-09
N022192-00286527762030-08-31U-16852015-04-30
N022192-002126068692030-09-22U-45042026-05-21
N022192-002126068692030-09-22U-45052026-05-21
N022192-00289996382030-10-28U-16742015-04-07
N022192-00290742552030-12-17U-16742015-07-28
N022192-00290727422031-01-16U-16742015-07-28
N022192-00290742562031-02-10U-16742015-07-28
N022192-00290742542031-12-28U-16742015-07-28
N022192-00385866102027-11-02U-16252015-01-08
N022192-003105704532028-03-28U-45622026-07-09
N022192-003105704532028-03-28U-45632026-07-09
N022192-00391571212030-04-05U-16742015-10-13
N022192-003105632592030-07-24U-45622026-07-09
N022192-003105632592030-07-24U-45632026-07-09
N022192-00386527762030-08-31U-16852015-04-30
N022192-003126068692030-09-22U-45042026-05-21
N022192-003126068692030-09-22U-45052026-05-21
N022192-00389996382030-10-28U-16742015-04-07
N022192-00390742552030-12-17U-16742015-07-28
N022192-00390727422031-01-16U-16742015-07-28
N022192-00390742562031-02-10U-16742015-07-28
N022192-00390742542031-12-28U-16742015-07-28
N022192-00485866102027-11-02U-16252015-01-08
N022192-004105704532028-03-28U-45622026-07-09
N022192-004105704532028-03-28U-45632026-07-09
N022192-00491571212030-04-05U-16742015-10-13
N022192-004105632592030-07-24U-45622026-07-09
N022192-004105632592030-07-24U-45632026-07-09
N022192-00486527762030-08-31U-16852015-04-30
N022192-004126068692030-09-22U-45042026-05-21
N022192-004126068692030-09-22U-45052026-05-21
N022192-00489996382030-10-28U-16742015-04-07
N022192-00490742552030-12-17U-16742015-07-28
N022192-00490727422031-01-16U-16742015-07-28
N022192-00490742562031-02-10U-16742015-07-28
N022192-00490742542031-12-28U-16742015-07-28
N022192-00585866102027-11-02U-16252015-01-08
N022192-005105704532028-03-28U-45622026-07-09
N022192-005105704532028-03-28U-45632026-07-09
N022192-00591571212030-04-05U-16742015-10-13
N022192-005105632592030-07-24U-45622026-07-09
N022192-005105632592030-07-24U-45632026-07-09
N022192-00586527762030-08-31U-16852015-04-30
N022192-005126068692030-09-22U-45042026-05-21
N022192-005126068692030-09-22U-45052026-05-21
N022192-00589996382030-10-28U-16742015-04-07
N022192-00590742552030-12-17U-16742015-07-28
N022192-00590727422031-01-16U-16742015-07-28
N022192-00590742562031-02-10U-16742015-07-28
N022192-00590742542031-12-28U-16742015-07-28
N022192-00685866102027-11-02U-16252015-01-08
N022192-006105704532028-03-28U-45622026-07-09
N022192-006105704532028-03-28U-45632026-07-09
N022192-00691571212030-04-05U-16742015-10-13
N022192-006105632592030-07-24U-45622026-07-09
N022192-006105632592030-07-24U-45632026-07-09
N022192-00686527762030-08-31U-16852015-04-30
N022192-006126068692030-09-22U-45042026-05-21
N022192-006126068692030-09-22U-45052026-05-21
N022192-00689996382030-10-28U-16742015-04-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N022192-001I-9392027-04-02
N022192-002I-9392027-04-02
N022192-003I-9392027-04-02
N022192-004I-9392027-04-02
N022192-005I-9392027-04-02
N022192-006I-9392027-04-02
N022192-007I-9392027-04-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022192-001FANAPT1MGTABLET / ORALRLD, RS2009-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002FANAPT2MGTABLET / ORALRLD2009-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003FANAPT4MGTABLET / ORALRLD2009-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-004FANAPT6MGTABLET / ORALRLD2009-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-005FANAPT8MGTABLET / ORALRLD2009-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-006FANAPT10MGTABLET / ORALRLD2009-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-007FANAPT12MGTABLET / ORALRLD2009-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022192-001FANAPT1MGTABLET / ORALRLD, RS2009-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-002FANAPT2MGTABLET / ORALRLD2009-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-003FANAPT4MGTABLET / ORALRLD2009-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-004FANAPT6MGTABLET / ORALRLD2009-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-005FANAPT8MGTABLET / ORALRLD2009-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-006FANAPT10MGTABLET / ORALRLD2009-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-007FANAPT12MGTABLET / ORALRLD2009-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-001FANAPT1MGTABLET / ORALRLD, RS2009-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-002FANAPT2MGTABLET / ORALRLD2009-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-003FANAPT4MGTABLET / ORALRLD2009-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-004FANAPT6MGTABLET / ORALRLD2009-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-005FANAPT8MGTABLET / ORALRLD2009-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-006FANAPT10MGTABLET / ORALRLD2009-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-007FANAPT12MGTABLET / ORALRLD2009-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022192-001FANAPT1MGTABLET / ORALRLD, RS2009-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-002FANAPT2MGTABLET / ORALRLD2009-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-003FANAPT4MGTABLET / ORALRLD2009-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-004FANAPT6MGTABLET / ORALRLD2009-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-005FANAPT8MGTABLET / ORALRLD2009-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-006FANAPT10MGTABLET / ORALRLD2009-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-007FANAPT12MGTABLET / ORALRLD2009-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-001FANAPT1MGTABLET / ORALRLD, RS2009-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-002FANAPT2MGTABLET / ORALRLD2009-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-003FANAPT4MGTABLET / ORALRLD2009-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-004FANAPT6MGTABLET / ORALRLD2009-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-005FANAPT8MGTABLET / ORALRLD2009-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-006FANAPT10MGTABLET / ORALRLD2009-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-007FANAPT12MGTABLET / ORALRLD2009-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-001FANAPT1MGTABLET / ORALRLD, RS2009-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-002FANAPT2MGTABLET / ORALRLD2009-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-003FANAPT4MGTABLET / ORALRLD2009-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-004FANAPT6MGTABLET / ORALRLD2009-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-005FANAPT8MGTABLET / ORALRLD2009-05-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-006AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022192-007AB15c6f7cd8ea54…
2019-07-19 19:46 UTC2019-07N022192-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022192-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022192-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022192-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022192-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022192-006AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022192-007AB1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-004AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-005AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-006AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022192-007AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 68 · 2,709 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022192-00185866102027-11-02U-16252015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-001105704532028-03-28U-45622026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-001105704532028-03-28U-45632026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00191571212030-04-05U-16742015-10-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-001105632592030-07-24U-45622026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-001105632592030-07-24U-45632026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00186527762030-08-31U-16852015-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-001126068692030-09-22U-45042026-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-001126068692030-09-22U-45052026-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00189996382030-10-28U-16742015-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00190742552030-12-17U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00190727422031-01-16U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00190742562031-02-10U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00190742542031-12-28U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00285866102027-11-02U-16252015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002105704532028-03-28U-45622026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002105704532028-03-28U-45632026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00291571212030-04-05U-16742015-10-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002105632592030-07-24U-45622026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002105632592030-07-24U-45632026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00286527762030-08-31U-16852015-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002126068692030-09-22U-45042026-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002126068692030-09-22U-45052026-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00289996382030-10-28U-16742015-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00290742552030-12-17U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00290727422031-01-16U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00290742562031-02-10U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00290742542031-12-28U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00385866102027-11-02U-16252015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003105704532028-03-28U-45622026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003105704532028-03-28U-45632026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00391571212030-04-05U-16742015-10-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003105632592030-07-24U-45622026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003105632592030-07-24U-45632026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00386527762030-08-31U-16852015-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003126068692030-09-22U-45042026-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003126068692030-09-22U-45052026-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00389996382030-10-28U-16742015-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00390742552030-12-17U-16742015-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-00390727422031-01-16U-16742015-07-28caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N022192-001I-9392027-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-002I-9392027-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-003I-9392027-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-004I-9392027-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-005I-9392027-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-006I-9392027-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022192-007I-9392027-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022192-001I-9392027-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-002I-9392027-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-003I-9392027-04-02011fe1cb6892…
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2026-02-19 14:30 UTC2026-02N022192-006I-9392027-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022192-007I-9392027-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-001I-9392027-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-002I-9392027-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-003I-9392027-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-004I-9392027-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-005I-9392027-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-006I-9392027-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022192-007I-9392027-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022192-001I-9392027-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022192-002I-9392027-04-026a471c1ec25d…
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2025-08-23 18:47 UTC2025-08N022192-007I-9392027-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-001I-9392027-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-002I-9392027-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-003I-9392027-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-004I-9392027-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-005I-9392027-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-006I-9392027-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022192-007I-9392027-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-001I-9392027-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-002I-9392027-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-003I-9392027-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-004I-9392027-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022192-005I-9392027-04-02b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
FANAPT
Listing expiration
2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VPO7KJ050NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
848722Internal RxNorm lookup
848726Internal RxNorm lookup
848728Internal RxNorm lookup
848730Internal RxNorm lookup
848732Internal RxNorm lookup
848734Internal RxNorm lookup
848736Internal RxNorm lookup
848738Internal RxNorm lookup
848740Internal RxNorm lookup
848742Internal RxNorm lookup
848744Internal RxNorm lookup
848746Internal RxNorm lookup
848748Internal RxNorm lookup
848750Internal RxNorm lookup
848751Internal RxNorm lookup
848752Internal RxNorm lookup
2714234Internal RxNorm lookup
2714235Internal RxNorm lookup
2720356Internal RxNorm lookup
2720357Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33f60b40-3fca-11de-8f56-0002a5d5c51bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c2441bbe-3ea0-4d2c-96a6-138bc08a4e8cProduct name220170213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43068-114-03FANAPT1 in 1 DOSE PACKKIT135
43068-114-03FANAPT1 in 1 BLISTER PACKKIT135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43068-114-03EA - Each43068-1141985e3d7-1c6e-4ac9-8422-c8e7ad35c33512025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ILOPERIDONEACTIVE INGREDIENTVPO7KJ050NFANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
ILOPERIDONEACTIVE MOIETYVPO7KJ050NFANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43068-114FANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]33Current NDC, 2 package rows20250514_33f60b40-3fca-11de-8f56-0002a5d5c51b.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FANAPTILOPERIDONEVanda Pharmaceuticals Inc.33f60b40-3fca-11de-8f56-0002a5d5c51b2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022192
application number: NDA022192
ndc (product): 43068-114

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848752{2 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 4 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack]BPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714235{4 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack C]BPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720357{6 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) / 2 (iloperidone 8 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack B]BPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
848751{2 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 4 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) } PackGPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714234{4 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) } PackGPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720356{6 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) / 2 (iloperidone 8 MG Oral Tablet) } PackGPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
848726Fanapt 1 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848730Fanapt 10 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848734Fanapt 12 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848738Fanapt 2 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848742Fanapt 4 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848746Fanapt 6 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848750Fanapt 8 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848752Fanapt Titration Pack APSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720357Fanapt Titration Pack BPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714235Fanapt Titration Pack CPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848722iloperidone 1 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848751iloperidone 1 MG Oral Tablet (2) / iloperidone 2 MG Oral Tablet (2) / iloperidone 4 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack APSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714234iloperidone 1 MG Oral Tablet (4) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack CPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720356iloperidone 1 MG Oral Tablet (6) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) / iloperidone 8 MG Oral Tablet (2) Titration Pack BPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848728iloperidone 10 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848732iloperidone 12 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848736iloperidone 2 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848740iloperidone 4 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848744iloperidone 6 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848748iloperidone 8 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848726iloperidone 1 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848730iloperidone 10 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848734iloperidone 12 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848738iloperidone 2 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848742iloperidone 4 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848746iloperidone 6 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848750iloperidone 8 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848722iloperidone 1 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848728iloperidone 10 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848732iloperidone 12 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848736iloperidone 2 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848740iloperidone 4 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848744iloperidone 6 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848748iloperidone 8 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848726Fanapt 1 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848730Fanapt 10 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848734Fanapt 12 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848738Fanapt 2 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848742Fanapt 4 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848746Fanapt 6 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848750Fanapt 8 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848752Fanapt Titration Pack ASY33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720357Fanapt Titration Pack BSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714235Fanapt Titration Pack CSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714234iloperidone 1 MG Oral Tablet (4) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack CSY33f60b40-3fca-11de-8f56-0002a5d5c51b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43068-114-03430680114031 BLISTER PACK in 1 DOSE PACK (43068-114-03) / 1 KIT in 1 BLISTER PACK1 blister pack2025-05-01NoNoCurrent