Paliperidone

Product NDC
0591-3694
11-digit product format
005913694
Labeler code
0591
Product ID
0591-3694_b168851f-ad1b-4391-857e-805f3b645711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA202645
Marketing category
ANDA
Marketing start
2015-09-24
Marketing end
0000-00-00
Substance
PALIPERIDONE
Active strength
6 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3694-19EA - Each0591-369488a6a14e-3f8e-4ce7-9325-4eae5ef204e712015-10-02
0591-3694-30EA - Each0591-369456351f6f-1a02-46f6-acf4-98203d36e07112015-10-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN94e12b70-fe83-4b2d-86b0-19d8303863032
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD94e12b70-fe83-4b2d-86b0-19d8303863032
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY94e12b70-fe83-4b2d-86b0-19d8303863032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3694-10005913694101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3694-10) 2015-09-240000-00-00NoNoCurrent
0591-3694-190059136941990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3694-19) 2015-09-240000-00-00NoNoCurrent
0591-3694-300059136943030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3694-30) 2015-09-240000-00-00NoNoCurrent