FDA.reportPublic FDA data

Paliperidone

Product NDC
42291-916
11-digit product format
422910916
Labeler code
42291
Product ID
42291-916_48bf98f0-9cf7-351e-e063-6394a90ab72b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA204707
Marketing category
ANDA
Marketing start
2023-07-28
Substance
PALIPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paliperidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii838F01T721
Rxcui672567, 672569, 672571, 866103

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-916-30Paliperidone30 in 1 BOTTLETABLET, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-916-30EA - Each42291-916604e1141-14e2-471a-9e03-2d0b730b955712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-916PALIPERIDONE TABLET, EXTENDED RELEASE [AVKARE]2Current NDC, 1 package rows20231118_018cf3ca-bee9-23a6-e063-6394a90ad905.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN018cf3ca-bee9-23a6-e063-6394a90ad9053
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD018cf3ca-bee9-23a6-e063-6394a90ad9053
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY018cf3ca-bee9-23a6-e063-6394a90ad9053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-916-304229109163030 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-916-30) 2023-07-28NoNoCurrent