FDA.reportPublic FDA data

Paliperidone

Product NDC
70518-4267
11-digit product format
705184267
Labeler code
70518
Product ID
70518-4267_400ab61f-5daf-6925-e063-6394a90ae1f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205618
Marketing category
ANDA
Marketing start
2025-01-27
Substance
PALIPERIDONE
Active strength
9 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
PALIPERIDONE9 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii838F01T721
Rxcui672571

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
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4267-0Paliperidone30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE303
70518-4267-1Paliperidone30 in 1 BOXTABLET, EXTENDED RELEASE303
70518-4267-2Paliperidone1 in 1 POUCHTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4267PALIPERIDONE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]2Current NDC, 3 package rows20250130_f13d3678-a861-42ba-be44-0d89f1b66ef3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSNf13d3678-a861-42ba-be44-0d89f1b66ef33
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCDf13d3678-a861-42ba-be44-0d89f1b66ef33
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSYf13d3678-a861-42ba-be44-0d89f1b66ef33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4267-07051842670030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4267-0) 2025-01-27NoNoHistorical
70518-4267-17051842670130 POUCH in 1 BOX (70518-4267-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4267-2) 30 pouch2025-01-28NoNoHistorical
70518-4267-2705184267021 in 1 POUCHHistorical