FDA.reportPublic FDA data

Paliperidone

Product NDC
65162-280
11-digit product format
651620280
Labeler code
65162
Product ID
65162-280_d01cb993-8ed1-4746-ad80-d95d3025c3ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204707
Marketing category
ANDA
Marketing start
2019-09-24
Substance
PALIPERIDONE
Active strength
1.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii838F01T721
Rxcui672567, 672569, 672571, 866103

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-280-03Paliperidone30 in 1 BOTTLETABLET, EXTENDED RELEASE3016
65162-280-09Paliperidone90 in 1 BOTTLETABLET, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-280-03EA - Each65162-28097027130-f255-4528-a978-226cc3660c6e12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-280PALIPERIDONE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 2 package rows20250321_7b269778-803b-4ce2-a8c0-636fb131d16a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN7b269778-803b-4ce2-a8c0-636fb131d16a16
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN7b269778-803b-4ce2-a8c0-636fb131d16a16
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN7b269778-803b-4ce2-a8c0-636fb131d16a16
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN7b269778-803b-4ce2-a8c0-636fb131d16a16
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD7b269778-803b-4ce2-a8c0-636fb131d16a16
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD7b269778-803b-4ce2-a8c0-636fb131d16a16
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD7b269778-803b-4ce2-a8c0-636fb131d16a16
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD7b269778-803b-4ce2-a8c0-636fb131d16a16
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY7b269778-803b-4ce2-a8c0-636fb131d16a16
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY7b269778-803b-4ce2-a8c0-636fb131d16a16
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY7b269778-803b-4ce2-a8c0-636fb131d16a16
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY7b269778-803b-4ce2-a8c0-636fb131d16a16
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-280-036516202800330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-03) 2019-09-240000-00-00NoNoCurrent
65162-280-096516202800990 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-09) 2019-09-240000-00-00NoNoCurrent