erzofri extended-release

Generic: paliperidone palmitate

Labeler: shandong luye pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name erzofri extended-release
Generic Name paliperidone palmitate
Labeler shandong luye pharmaceutical co., ltd.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

paliperidone palmitate 117 mg/.75mL

Manufacturer
Shandong Luye Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 72526-107
Product ID 72526-107_f49314e5-0d0a-4587-92a3-293fe1f1b657
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216352
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72526107
Hyphenated Format 72526-107

Supplemental Identifiers

RxCUI
858048 858052 858054 858056 858073 2699342 2699348 2699350 2699351 2699352 2699353 2699354
UNII
R8P8USM8FR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name erzofri extended-release (source: ndc)
Generic Name paliperidone palmitate (source: ndc)
Application Number NDA216352 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 117 mg/.75mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 KIT (72526-107-11) / .75 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

72526-107-11 1 SYRINGE, GLASS in 1 KIT (72526-107-11) / .75 mL in 1 SYRINGE, GLASS

Ingredients (1)

paliperidone palmitate (117 mg/.75mL)

Linked Drug Pages (1)

Erzofri extended-release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "f49314e5-0d0a-4587-92a3-293fe1f1b657", "openfda": {"unii": ["R8P8USM8FR"], "rxcui": ["858048", "858052", "858054", "858056", "858073", "2699342", "2699348", "2699350", "2699351", "2699352", "2699353", "2699354"], "spl_set_id": ["492bf9dd-868e-421a-92db-8cca8973aac1"], "manufacturer_name": ["Shandong Luye Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 KIT (72526-107-11)  / .75 mL in 1 SYRINGE, GLASS", "package_ndc": "72526-107-11", "marketing_start_date": "20241210"}], "brand_name": "Erzofri extended-release", "product_id": "72526-107_f49314e5-0d0a-4587-92a3-293fe1f1b657", "dosage_form": "INJECTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72526-107", "generic_name": "paliperidone palmitate", "labeler_name": "Shandong Luye Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erzofri extended-release", "active_ingredients": [{"name": "PALIPERIDONE PALMITATE", "strength": "117 mg/.75mL"}], "application_number": "NDA216352", "marketing_category": "NDA", "marketing_start_date": "20241210", "listing_expiration_date": "20261231"}