FDA.reportPublic FDA data

Paliperidone

Product NDC
47335-765
11-digit product format
473350765
Labeler code
47335
Product ID
47335-765_cdd30050-6959-4bea-8830-ed72bde5d4ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205618
Marketing category
ANDA
Marketing start
2018-08-01
Substance
PALIPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE3 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
47335-765-83Paliperidone30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3012
47335-765-88Paliperidone100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-765-83EA - Each47335-765974dea37-28e8-4c10-8da4-68eeb8dd6e6d12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-765PALIPERIDONE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 2 package rows20250227_0dc3a9b2-2edf-4fa2-a949-459b4218e763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN0dc3a9b2-2edf-4fa2-a949-459b4218e76312
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD0dc3a9b2-2edf-4fa2-a949-459b4218e76312
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD0dc3a9b2-2edf-4fa2-a949-459b4218e76312
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD0dc3a9b2-2edf-4fa2-a949-459b4218e76312
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD0dc3a9b2-2edf-4fa2-a949-459b4218e76312
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY0dc3a9b2-2edf-4fa2-a949-459b4218e76312
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN528a962a-4924-4c48-93ce-6ab1f019e52c8
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN528a962a-4924-4c48-93ce-6ab1f019e52c8
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN528a962a-4924-4c48-93ce-6ab1f019e52c8
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD528a962a-4924-4c48-93ce-6ab1f019e52c8
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD528a962a-4924-4c48-93ce-6ab1f019e52c8
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD528a962a-4924-4c48-93ce-6ab1f019e52c8
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY528a962a-4924-4c48-93ce-6ab1f019e52c8
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY528a962a-4924-4c48-93ce-6ab1f019e52c8
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY528a962a-4924-4c48-93ce-6ab1f019e52c8
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSNc6d80cc0-596e-49b9-8216-34e7b01e2df24
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSNc6d80cc0-596e-49b9-8216-34e7b01e2df24
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCDc6d80cc0-596e-49b9-8216-34e7b01e2df24
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCDc6d80cc0-596e-49b9-8216-34e7b01e2df24
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSYc6d80cc0-596e-49b9-8216-34e7b01e2df24
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSYc6d80cc0-596e-49b9-8216-34e7b01e2df24
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN85cdf6fb-d59f-4231-bd21-c8435df5930d3
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD85cdf6fb-d59f-4231-bd21-c8435df5930d3
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY85cdf6fb-d59f-4231-bd21-c8435df5930d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-765-834733507658330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-765-83) 2018-08-010000-00-00NoNoCurrent
47335-765-8847335076588100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-765-88) 2018-08-010000-00-00NoNoCurrent