ILOPERIDONE

Product NDC
0378-0632
11-digit product format
003780632
Labeler code
0378
Product ID
0378-0632_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
4 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207231-001ILOPERIDONEILOPERIDONE1MGTABLET / ORAL2016-11-28
A207231-002ILOPERIDONEILOPERIDONE2MGTABLET / ORAL2016-11-28
A207231-003ILOPERIDONEILOPERIDONE4MGTABLET / ORAL2016-11-28
A207231-004ILOPERIDONEILOPERIDONE6MGTABLET / ORAL2016-11-28
A207231-005ILOPERIDONEILOPERIDONE8MGTABLET / ORAL2016-11-28
A207231-006ILOPERIDONEILOPERIDONE10MGTABLET / ORAL2016-11-28
A207231-007ILOPERIDONEILOPERIDONE12MGTABLET / ORAL2016-11-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207231-001ILOPERIDONE1MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207231-002ILOPERIDONE2MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207231-003ILOPERIDONE4MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207231-004ILOPERIDONE6MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207231-005ILOPERIDONE8MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207231-006ILOPERIDONE10MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207231-007ILOPERIDONE12MGTABLET / ORAL2016-11-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207231-001ILOPERIDONE1MGTABLET / ORAL2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207231-002ILOPERIDONE2MGTABLET / ORAL2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207231-003ILOPERIDONE4MGTABLET / ORAL2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207231-004ILOPERIDONE6MGTABLET / ORAL2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207231-005ILOPERIDONE8MGTABLET / ORAL2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207231-006ILOPERIDONE10MGTABLET / ORAL2016-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207231-007ILOPERIDONE12MGTABLET / ORAL2016-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-001ILOPERIDONE1MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-002ILOPERIDONE2MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-003ILOPERIDONE4MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-004ILOPERIDONE6MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-005ILOPERIDONE8MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-006ILOPERIDONE10MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207231-007ILOPERIDONE12MGTABLET / ORAL2016-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207231-001ILOPERIDONE1MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207231-002ILOPERIDONE2MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207231-003ILOPERIDONE4MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207231-004ILOPERIDONE6MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207231-005ILOPERIDONE8MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207231-006ILOPERIDONE10MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207231-007ILOPERIDONE12MGTABLET / ORAL2016-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-001ILOPERIDONE1MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-002ILOPERIDONE2MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-003ILOPERIDONE4MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-004ILOPERIDONE6MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-005ILOPERIDONE8MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-006ILOPERIDONE10MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207231-007ILOPERIDONE12MGTABLET / ORAL2016-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207231-001ILOPERIDONE1MGTABLET / ORAL2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207231-002ILOPERIDONE2MGTABLET / ORAL2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207231-003ILOPERIDONE4MGTABLET / ORAL2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207231-004ILOPERIDONE6MGTABLET / ORAL2016-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207231-005ILOPERIDONE8MGTABLET / ORAL2016-11-28b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A207231-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207231-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207231-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207231-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207231-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207231-006AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207231-007AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
ILOPERIDONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ILOPERIDONE4 mg/1

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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
848722Internal RxNorm lookup
848728Internal RxNorm lookup
848732Internal RxNorm lookup
848736Internal RxNorm lookup
848740Internal RxNorm lookup
848744Internal RxNorm lookup
848748Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeb0fcfd-e4e8-4fb1-9635-901dc9446235Available 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
0378-0632-01ILOPERIDONE100 in 1 BOTTLETABLET10010
0378-0632-88ILOPERIDONE10 in 1 CARTONTABLET1010
0378-0632-88ILOPERIDONE10 in 1 BLISTER PACKTABLET1010
0378-0632-91ILOPERIDONE60 in 1 BOTTLETABLET6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0632ILOPERIDONE TABLET [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 4 package rows20250316_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ILOPERIDONEILOPERIDONEMylan Pharmaceuticals Inc.eeb0fcfd-e4e8-4fb1-9635-901dc94462352025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207231
application number: ANDA207231
ndc (product): 0378-0632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848722iloperidone 1 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848728iloperidone 10 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848732iloperidone 12 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848736iloperidone 2 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848740iloperidone 4 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848744iloperidone 6 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848748iloperidone 8 MG Oral TabletPSNeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848722iloperidone 1 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848728iloperidone 10 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848732iloperidone 12 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848736iloperidone 2 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848740iloperidone 4 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848744iloperidone 6 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510
848748iloperidone 8 MG Oral TabletSCDeeb0fcfd-e4e8-4fb1-9635-901dc944623510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0632-0100378063201100 TABLET in 1 BOTTLE (0378-0632-01) 100 tablet2017-03-200000-00-00NoNoCurrent
0378-0632-880037806328810 BLISTER PACK in 1 CARTON (0378-0632-88) / 10 TABLET in 1 BLISTER PACK10 blister pack2017-03-200000-00-00NoNoCurrent
0378-0632-910037806329160 TABLET in 1 BOTTLE (0378-0632-91) 60 tablet2017-03-200000-00-00NoNoCurrent