FDA.reportPublic FDA data

Paliperidone

Product NDC
69367-435
11-digit product format
693670435
Labeler code
69367
Product ID
69367-435_10e430a8-a911-4b08-8efb-694387c50531
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA218755
Marketing category
ANDA
Marketing start
2025-12-09
Substance
PALIPERIDONE
Active strength
9 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218755-001PALIPERIDONEPALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04
A218755-002PALIPERIDONEPALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04
A218755-003PALIPERIDONEPALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04
A218755-004PALIPERIDONEPALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A218755-001AB
A218755-002AB
A218755-003AB
A218755-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218755-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A218755-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A218755-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A218755-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218755-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218755-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218755-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218755-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2025-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2025-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2025-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2025-09-0431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2025-09-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218755-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218755-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218755-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218755-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218755-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218755-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218755-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218755-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218755-004AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218755-004AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
838F01T721Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
672567Internal RxNorm lookup
672569Internal RxNorm lookup
672571Internal RxNorm lookup
866103Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1745a460-5e3a-4a1f-8eb3-64bb112f47a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3752075e-d817-45ea-9aa1-8dc0301cf2aaProduct name120251114
893dce58-6330-4a9a-ab03-5ffd7148e184Product name120250311
b6847380-b533-d626-e29e-10b60b2ad451Product name920250303
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-435-30Paliperidone30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-435-30EA - Each69367-4351bd4cc46-d9d1-4aa2-9b2f-a5b983562b5d12026-02-05

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PaliperidonePALIPERIDONEBryant Ranch Prepackff5ef11c-5c22-4a8e-89dd-4740f0ebf6342026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218755
application number: ANDA218755
PaliperidonePALIPERIDONEBryant Ranch Prepackf75e884e-1883-45d7-ac9b-4a6c63f2185e2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218755
application number: ANDA218755
PaliperidonePALIPERIDONEBryant Ranch Prepackf0c13f91-0232-48b0-aa13-121805b8da132026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218755
application number: ANDA218755
PaliperidonePALIPERIDONEBryant Ranch Prepackc7472b50-fa6c-4127-a4b3-3645436274ee2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218755
application number: ANDA218755
PaliperidonePALIPERIDONEWestminster Pharmaceuticals, LLC1745a460-5e3a-4a1f-8eb3-64bb112f47a42026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218755
application number: ANDA218755
ndc (product): 69367-435
PALIPERIDONEPALIPERIDONEEskayef Pharmaceuticals Limitedde95e29f-a030-4777-a601-874500ab8e912025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218755
application number: ANDA218755

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSNf0c13f91-0232-48b0-aa13-121805b8da13100
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCDf0c13f91-0232-48b0-aa13-121805b8da13100
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSYf0c13f91-0232-48b0-aa13-121805b8da13100
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN1745a460-5e3a-4a1f-8eb3-64bb112f47a42
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN1745a460-5e3a-4a1f-8eb3-64bb112f47a42
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN1745a460-5e3a-4a1f-8eb3-64bb112f47a42
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN1745a460-5e3a-4a1f-8eb3-64bb112f47a42
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD1745a460-5e3a-4a1f-8eb3-64bb112f47a42
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD1745a460-5e3a-4a1f-8eb3-64bb112f47a42
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD1745a460-5e3a-4a1f-8eb3-64bb112f47a42
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD1745a460-5e3a-4a1f-8eb3-64bb112f47a42
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY1745a460-5e3a-4a1f-8eb3-64bb112f47a42
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY1745a460-5e3a-4a1f-8eb3-64bb112f47a42
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY1745a460-5e3a-4a1f-8eb3-64bb112f47a42
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY1745a460-5e3a-4a1f-8eb3-64bb112f47a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-435-306936704353030 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-435-30) 2025-12-09NoNoCurrent