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 156 mg/mL

Manufacturer
Shandong Luye Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 72526-108
Product ID 72526-108_4c9a70a9-b1b5-b462-e063-6294a90adefd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216352
Listing Expiration 2027-12-31
Marketing Start 2024-12-10

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72526108
Hyphenated Format 72526-108

Supplemental Identifiers

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
  • 156 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 KIT (72526-108-11) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

72526-108-11 1 SYRINGE, GLASS in 1 KIT (72526-108-11) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

paliperidone palmitate (156 mg/mL)

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": "4c9a70a9-b1b5-b462-e063-6294a90adefd", "openfda": {"unii": ["R8P8USM8FR"], "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 (72526-108-11)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "72526-108-11", "marketing_start_date": "20241210"}], "brand_name": "Erzofri extended-release", "product_id": "72526-108_4c9a70a9-b1b5-b462-e063-6294a90adefd", "dosage_form": "INJECTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72526-108", "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": "156 mg/mL"}], "application_number": "NDA216352", "marketing_category": "NDA", "marketing_start_date": "20241210", "listing_expiration_date": "20271231"}