Paliperidone

Product NDC
0378-3979
11-digit product format
003783979
Labeler code
0378
Product ID
0378-3979_222509f8-7c2a-404d-b942-e876b7c636ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paliperidone
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA203802
Marketing category
ANDA
Marketing start
2015-09-24
Marketing end
2023-11-29
Substance
PALIPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3979-93EA - Each0378-3979cc76419a-ec3a-4f71-9a53-2812ed004c4912015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3979-930037839799330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3979-93) 2015-09-242023-11-29NoNoCurrent