Paliperidone NDC 72819-160

NDC codes

FDA NDC Directory

Product NDC (as listed)72819-160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72819-0160Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
72819-160-03	72819016003	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-160-03)Marketed from Apr 27, 2022

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): Paliperidone
Generic name (nonproprietary): paliperidone
Active ingredients: Paliperidone — 9 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Archis Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203802
Marketing start: Apr 27, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 72819-160_4745a6d1-d9f5-2ff9-e063-6394a90a2825SPL ID 4745a6d1-d9f5-2ff9-e063-6394a90a2825SPL set ID e713556e-028e-0f4c-e053-2995a90a9e9fRxCUI 672567, 672569, 672571UNII 838F01T721
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472819016003 followed by a unit qualifier and the quantity

Package 72819-0160-03. 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 Dec 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. ( 1.2 ) Efficacy was established in two 6-week trials in adult patients. ( 14.2 ) 1.1 Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ] . The efficacy of paliperidone extended-release tablets in schizophreni…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203802

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203802
Product	Strength	Form · route	Labeler	Product NDC
Paliperidone	Paliperidone 6 mg/1	Tablet, Film coated, Extended releaseOral	Archis Pharma LLC	72819-159
Paliperidone	Paliperidone 3 mg/1	Tablet, Film coated, Extended releaseOral	Archis Pharma LLC	72819-158