Paliperidone

Product NDC
0591-3693
11-digit product format
005913693
Labeler code
0591
Product ID
0591-3693_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
3 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3693-19EA - Each0591-3693430bdfe0-3755-4165-b691-b7e5da850fc012015-10-02
0591-3693-30EA - Each0591-369379235460-1d2e-4acd-9b88-e1d2c7c7ffdc12015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3693-10005913693101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3693-10) 2015-09-240000-00-00NoNoCurrent
0591-3693-190059136931990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3693-19) 2015-09-240000-00-00NoNoCurrent
0591-3693-300059136933030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3693-30) 2015-09-240000-00-00NoNoCurrent