Paliperidone

Product NDC
72819-157
11-digit product format
728190157
Labeler code
72819
Product ID
72819-157_e713695a-df6d-0bc6-e053-2a95a90a31ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paliperidone
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Archis Pharma LLC
Application
ANDA203802
Marketing category
ANDA
Marketing start
2022-05-31
Marketing end
0000-00-00
Substance
PALIPERIDONE
Active strength
2 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
72819-157-03EA - Each72819-157e9259ad1-9c68-4ffe-8b3f-34063b7fb5fe12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72819-157PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ARCHIS PHARMA LLC]2Legacy NDC20230929_e713556e-028e-0f4c-e053-2995a90a9e9f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72819-157-037281901570330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-157-03) 2022-05-310000-00-00NoNoCurrent