Paliperidone

Product NDC
0591-3692
11-digit product format
005913692
Labeler code
0591
Product ID
0591-3692_b168851f-ad1b-4391-857e-805f3b645711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA202645
Marketing category
ANDA
Marketing start
2015-09-24
Marketing end
0000-00-00
Substance
PALIPERIDONE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0591-3692DDiscontinued by firm2026-08-17
excluded packagepackage0591-36920591-3692-30DDiscontinued 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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-3692-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-3692-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-3692-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-3692-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-3692-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-3692-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-3692-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-3692-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-3692-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-3692-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-3692-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-3692-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202645-001PALIPERIDONEPALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-03
A202645-002PALIPERIDONEPALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-03
A202645-003PALIPERIDONEPALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-03
A202645-004PALIPERIDONEPALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-03

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202645-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORAL2015-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202645-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORAL2015-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202645-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORAL2015-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202645-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORAL2015-08-03d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202645-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202645-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202645-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202645-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202645-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202645-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202645-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202645-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202645-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202645-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202645-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202645-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202645-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202645-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202645-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202645-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202645-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202645-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202645-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202645-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202645-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202645-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202645-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202645-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202645-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202645-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202645-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202645-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202645-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202645-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202645-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202645-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202645-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202645-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202645-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202645-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202645-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202645-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202645-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202645-004AB187673890dc5c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3692-30EA - Each0591-3692276818fc-60e9-4112-b202-f956afdea02a12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PALIPERIDONEACTIVE INGREDIENT838F01T721PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
PALIPERIDONEACTIVE MOIETY838F01T721PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POVIDONESINACTIVE INGREDIENTFZ989GH94EPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TRIACETININACTIVE INGREDIENTXHX3C3X673PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3692-10005913692101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3692-10) 2015-09-240000-00-00NoNoCurrent
0591-3692-190059136921990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3692-19) 2015-09-240000-00-00NoNoCurrent
0591-3692-300059136923030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3692-30) 2015-09-240000-00-00NoNoCurrent