Paliperidone NDC 43975-350

NDC codes

FDA NDC Directory

Product NDC (as listed)43975-350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43975-0350Add 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
43975-350-03	43975035003	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03)Marketed from Nov 27, 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: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204452
Marketing start: Nov 27, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 43975-350_57a9842e-b847-e3c7-e063-6294a90af4fcSPL ID 57a9842e-b847-e3c7-e063-6294a90af4fcSPL set ID bbbaa057-f587-4eb9-a0d2-463dbcd57661RxCUI 672567, 672569, 672571, 866103UNII 838F01T721UPC 0343975352034, 0343975350030, 0343975349034, 0343975351037
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

N443975035003 followed by a unit qualifier and the quantity

Package 43975-0350-03. 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 Jul 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Paliperidone is 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 in schizophrenia was established in three …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204452

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

FDA NDC Directory listings under ANDA 204452
Product	Strength	Form · route	Labeler	Product NDC
Paliperidone	Paliperidone 6 mg/1	Tablet, Extended releaseOral	ANI Pharmaceuticals, Inc.	43975-351
Paliperidone	Paliperidone 1.5 mg/1	Tablet, Extended releaseOral	ANI Pharmaceuticals, Inc.	43975-349
Paliperidone	Paliperidone 9 mg/1	Tablet, Extended releaseOral	ANI Pharmaceuticals, Inc.	43975-352