FDA.reportPublic FDA data

Erzofri extended-release

Product NDC
72526-110
11-digit product format
725260110
Labeler code
72526
Product ID
72526-110_4c9a70a9-b1b5-b462-e063-6294a90adefd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paliperidone palmitate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Shandong Luye Pharmaceutical Co., Ltd.
Application
NDA216352
Marketing category
NDA
Marketing start
2024-12-10
Substance
PALIPERIDONE PALMITATE
Active strength
351 mg/2.25mL
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
Erzofri extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE PALMITATE351 mg/2.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8P8USM8FR
Rxcui858048, 858052, 858054, 858056, 858073, 2699342, 2699348, 2699350, 2699351, 2699352, 2699353, 2699354

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72526-110-11Erzofri extended-release2.25 mL in 1 SYRINGE, GLASSINJECTION2.257
72526-110-11Erzofri extended-release1 in 1 KITINJECTION17
72526-110-21Erzofri extended-release2.25 mL in 1 SYRINGE, GLASSINJECTION2.257
72526-110-21Erzofri extended-release1 in 1 KITINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72526-110-11ML - Milliliter72526-1100162d348-d77d-4765-99e6-2f9fed030beb12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72526-110ERZOFRI EXTENDED-RELEASE (PALIPERIDONE PALMITATE) INJECTION [SHANDONG LUYE PHARMACEUTICAL CO., LTD.]4Current NDC, 4 package rows20250321_492bf9dd-868e-421a-92db-8cca8973aac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2699350Erzofri 117 MG in 0.75 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
2699351Erzofri 156 MG in 1 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
2699352Erzofri 234 MG in 1.5 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
2699348Erzofri 351 MG in 2.25 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
2699353Erzofri 39 MG in 0.25 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
2699354Erzofri 78 MG in 0.5 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
858056paliperidone palmitate 117 MG in 0.75 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
858054paliperidone palmitate 156 MG in 1 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
858052paliperidone palmitate 234 MG in 1.5 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
2699342paliperidone palmitate 351 MG in 2.25 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
858073paliperidone palmitate 39 MG in 0.25 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
858048paliperidone palmitate 78 MG in 0.5 ML Prefilled SyringePSN492bf9dd-868e-421a-92db-8cca8973aac17
26993530.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]SBD492bf9dd-868e-421a-92db-8cca8973aac17
26993540.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]SBD492bf9dd-868e-421a-92db-8cca8973aac17
26993500.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]SBD492bf9dd-868e-421a-92db-8cca8973aac17
26993511 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]SBD492bf9dd-868e-421a-92db-8cca8973aac17
26993521.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]SBD492bf9dd-868e-421a-92db-8cca8973aac17
26993482.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]SBD492bf9dd-868e-421a-92db-8cca8973aac17
8580730.25 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD492bf9dd-868e-421a-92db-8cca8973aac17
8580480.5 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD492bf9dd-868e-421a-92db-8cca8973aac17
8580560.75 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD492bf9dd-868e-421a-92db-8cca8973aac17
8580541 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD492bf9dd-868e-421a-92db-8cca8973aac17
8580521.5 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD492bf9dd-868e-421a-92db-8cca8973aac17
26993422.25 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD492bf9dd-868e-421a-92db-8cca8973aac17
2699350Erzofri 117 MG per 0.75 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699350Erzofri 117 MG per 0.75 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699351Erzofri 156 MG per 1 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699351Erzofri 156 MG per 1 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699352Erzofri 234 MG per 1.5 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699352Erzofri 234 MG per 1.5 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699348Erzofri 351 MG per 2.25 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699348Erzofri 351 MG per 2.25 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699353Erzofri 39 MG per 0.25 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699353Erzofri 39 MG per 0.25 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699354Erzofri 78 MG per 0.5 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699354Erzofri 78 MG per 0.5 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
858056paliperidone palmitate 117 MG per 0.75 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
858054paliperidone palmitate 156 MG per 1 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
858052paliperidone palmitate 234 MG per 1.5 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699342paliperidone palmitate 351 MG per 2.25 ML Extended Release Injectable Suspension in a Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
2699342paliperidone palmitate 351 MG per 2.25 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
858073paliperidone palmitate 39 MG per 0.25 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17
858048paliperidone palmitate 78 MG per 0.5 ML Prefilled SyringeSY492bf9dd-868e-421a-92db-8cca8973aac17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72526-110-11725260110111 SYRINGE, GLASS in 1 KIT (72526-110-11) / 2.25 mL in 1 SYRINGE, GLASS2024-12-10NoNoHistorical
72526-110-21725260110211 SYRINGE, GLASS in 1 KIT (72526-110-21) / 2.25 mL in 1 SYRINGE, GLASS2025-03-20YesNoHistorical