Paliperidone

Product NDC
27241-276
11-digit product format
272410276
Labeler code
27241
Product ID
27241-276_96765b43-a41f-4bba-a582-0e130e813ad3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA218514
Marketing category
ANDA
Marketing start
2024-06-26
Substance
PALIPERIDONE
Active strength
1.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paliperidone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE1.5 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
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-276-30Paliperidone30 in 1 BOTTLETABLET, EXTENDED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-276-30EA - Each27241-2769c9a6491-efa1-417d-aaaa-f2f9d4beb09a12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-276PALIPERIDONE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]4Current NDC, 1 package rows20250305_71985eb4-07df-41c9-8b9a-85f39e92b7d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN71985eb4-07df-41c9-8b9a-85f39e92b7d04
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN71985eb4-07df-41c9-8b9a-85f39e92b7d04
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN71985eb4-07df-41c9-8b9a-85f39e92b7d04
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN71985eb4-07df-41c9-8b9a-85f39e92b7d04
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD71985eb4-07df-41c9-8b9a-85f39e92b7d04
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD71985eb4-07df-41c9-8b9a-85f39e92b7d04
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD71985eb4-07df-41c9-8b9a-85f39e92b7d04
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD71985eb4-07df-41c9-8b9a-85f39e92b7d04
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY71985eb4-07df-41c9-8b9a-85f39e92b7d04
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY71985eb4-07df-41c9-8b9a-85f39e92b7d04
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY71985eb4-07df-41c9-8b9a-85f39e92b7d04
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY71985eb4-07df-41c9-8b9a-85f39e92b7d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-276-302724102763030 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-276-30) 2024-06-26NoNoHistorical