Prescription drug · NDA
Erzofri extended-release (paliperidone palmitate) NDC 72526-105
Paliperidone palmitate 39 mg/.25mL · Injection · Intramuscular · Shandong Luye Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72526-105-11 | 72526010511 | 1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASSMarketed from Dec 10, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Erzofri extended-release
- Generic name (nonproprietary)
- paliperidone palmitate
- Active ingredients
- Paliperidone palmitate — 39 mg/.25mL
- Dosage form
- Injection
- Route
- Intramuscular
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216352
- Marketing start
- Listing expires
- Identifiers
- Product ID 72526-105_4c9a70a9-b1b5-b462-e063-6294a90adefdSPL ID 4c9a70a9-b1b5-b462-e063-6294a90adefdSPL set ID 492bf9dd-868e-421a-92db-8cca8973aac1RxCUI 858048, 858052, 858054, 858056, 858073, 2699342, 2699348, 2699350, 2699351, 2699352, 2699353, 2699354UNII R8P8USM8FR
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N472526010511followed by a unit qualifier and the quantityPackage 72526-0105-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ERZOFRI is indicated for the treatment of: Schizophrenia in adults . Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants . ERZOFRI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 216352
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Erzofri extended-releasepaliperidone palmitate | Paliperidone palmitate 117 mg/.75mL | InjectionIntramuscular | Shandong Luye Pharmaceutical Co., Ltd. | 72526-107 |
| Erzofri extended-releasepaliperidone palmitate | Paliperidone palmitate 78 mg/.5mL | InjectionIntramuscular | Shandong Luye Pharmaceutical Co., Ltd. | 72526-106 |
| Erzofri extended-releasepaliperidone palmitate | Paliperidone palmitate 351 mg/2.25mL | InjectionIntramuscular | Shandong Luye Pharmaceutical Co., Ltd. | 72526-110 |
| Erzofri extended-releasepaliperidone palmitate | Paliperidone palmitate 156 mg/mL | InjectionIntramuscular | Shandong Luye Pharmaceutical Co., Ltd. | 72526-108 |
| Erzofri extended-releasepaliperidone palmitate | Paliperidone palmitate 234 mg/1.5mL | InjectionIntramuscular | Shandong Luye Pharmaceutical Co., Ltd. | 72526-109 |