Paroxetine NDC 69367-335

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-335Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0335Add 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
69367-335-30	69367033530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-335-30)Marketed from Jul 26, 2021

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): Paroxetine
Generic name (nonproprietary): paroxetine
Active ingredients: Paroxetine hydrochloride — 12.5 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Westminster Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213485
Marketing start: Jul 26, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 69367-335_0a272d00-5b37-47b2-870a-0028ca799109SPL ID 0a272d00-5b37-47b2-870a-0028ca799109SPL set ID f39a2a7a-7a7e-4dd8-9704-54d9598504fbRxCUI 1738803, 1738805, 1738807UNII X2ELS050D8UPC 0369367337304
Pharmacologic class: Serotonin Reuptake Inhibitor

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

N469367033530 followed by a unit qualifier and the quantity

Package 69367-0335-30. 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 Oct 5, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213485

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

FDA NDC Directory listings under ANDA 213485
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride 25 mg/1	Tablet, Film coated, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-336
Paroxetine	Paroxetine hydrochloride 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-337