FDA.reportPublic FDA data

Paliperidone

Product NDC
47335-744
11-digit product format
473350744
Labeler code
47335
Product ID
47335-744_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
1.5 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
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
47335-744-83Paliperidone30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3012
47335-744-88Paliperidone100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-744-83EA - Each47335-744dd8ad381-64f5-4510-b7ef-8ec0f6c8b4a612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-744PALIPERIDONE 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-744-834733507448330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-744-83) 2018-08-010000-00-00NoNoCurrent
47335-744-8847335074488100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-744-88) 2018-08-010000-00-00NoNoCurrent