What is NDC 65162-281?

65162-281 is the product NDC for Paliperidone, Paliperidone 3 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Paliperidone?

64 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paliperidone NDC 65162-281 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0281Add 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
65162-281-03	6516202810365162028103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-03)Marketed from Sep 24, 2019
65162-281-09	6516202810965162028109	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-09)Marketed from Sep 24, 2019

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 — 3 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204707
Marketing start: Sep 24, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 65162-281_d01cb993-8ed1-4746-ad80-d95d3025c3acSPL ID d01cb993-8ed1-4746-ad80-d95d3025c3acSPL set ID 7b269778-803b-4ce2-a8c0-636fb131d16aRxCUI 672567, 672569, 672571, 866103UNII 838F01T721UPC 0365162280036, 0365162282030, 0365162281033, 0365162283037
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

N465162028103 followed by a unit qualifier and the quantity

Package 65162-0281-03. 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 Sep 5, 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 to 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 schizophrenia was es…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-281

What is NDC 65162-281?: 65162-281 is the product NDC for Paliperidone, Paliperidone 3 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paliperidone.
What is the active ingredient?: Paliperidone.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paliperidone?: 64 other product NDCs are listed under this name. See all Paliperidone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Paliperidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1630	67046-1630-03
Paliperidone	Paliperidone 1.5 mg/1	Tablet, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-432	69367-0432-30
Paliperidone	Paliperidone 3 mg/1	Tablet, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-433	69367-0433-30
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-434	69367-0434-30
Paliperidone	Paliperidone 9 mg/1	Tablet, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-435	69367-0435-30
Paliperidone	Paliperidone 1.5 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2648	72162-2648-03
Paliperidone	Paliperidone 3 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2649	72162-2649-03
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2650	72162-2650-03
Paliperidone	Paliperidone 9 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2651	72162-2651-03
Paliperidone	Paliperidone 1.5 mg/1	Tablet, Extended releaseOral	Eskayef Pharmaceuticals Limited	72658-1253	72658-1253-0172658-1253-0272658-1253-03

All 65 Paliperidone NDCs

Other NDCs under ANDA 204707

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

FDA NDC Directory listings under ANDA 204707
Product	Strength	Form · route	Labeler	Product NDC
Paliperidone	Paliperidone 1.5 mg/1	Tablet, Extended releaseOral	AvKARE	42291-915
Paliperidone	Paliperidone 3 mg/1	Tablet, Extended releaseOral	AvKARE	42291-916
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	AvKARE	42291-917
Paliperidone	Paliperidone 9 mg/1	Tablet, Extended releaseOral	AvKARE	42291-918
Paliperidone	Paliperidone 1.5 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-280
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-282
Paliperidone	Paliperidone 9 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-283
Paliperidone	Paliperidone 3 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1539
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1630