FDA.reportPublic FDA data

Paliperidone

Product NDC
0904-6935
11-digit product format
009046935
Labeler code
0904
Product ID
0904-6935_30f0d212-ed22-4d6e-9270-53a94f1d119c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paliperidone
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205618
Marketing category
ANDA
Marketing start
2018-08-01
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

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
0904-6935-61Paliperidone100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1008
0904-6935-61Paliperidone1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6935-61EA - Each0904-6935aea1e653-fdfe-437f-bd30-34b4170952b512020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6935PALIPERIDONE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250510_528a962a-4924-4c48-93ce-6ab1f019e52c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN528a962a-4924-4c48-93ce-6ab1f019e52c8
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN528a962a-4924-4c48-93ce-6ab1f019e52c8
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN528a962a-4924-4c48-93ce-6ab1f019e52c8
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD528a962a-4924-4c48-93ce-6ab1f019e52c8
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD528a962a-4924-4c48-93ce-6ab1f019e52c8
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD528a962a-4924-4c48-93ce-6ab1f019e52c8
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY528a962a-4924-4c48-93ce-6ab1f019e52c8
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY528a962a-4924-4c48-93ce-6ab1f019e52c8
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY528a962a-4924-4c48-93ce-6ab1f019e52c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6935-6100904693561100 BLISTER PACK in 1 CARTON (0904-6935-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-08-010000-00-00NoNoCurrent