What is NDC 69584-673?

69584-673 is the product NDC for paroxetine hydrochloride, Paroxetine hydrochloride 30 mg/1 tablet, film coated, listed with the FDA by Oxford Pharmaceuticals, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Oxford Pharmaceuticals, LLC, NDC labeler code 69584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for paroxetine hydrochloride?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

paroxetine hydrochloride NDC 69584-673

NDC codes

FDA NDC Directory

Product NDC (as listed)69584-673Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69584-0673Add 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
69584-673-03	6958406730369584067303	30 TABLET, FILM COATED in 1 BOTTLE (69584-673-03)Marketed from Nov 14, 2022
69584-673-09	6958406730969584067309	90 TABLET, FILM COATED in 1 BOTTLE (69584-673-09)Marketed from Nov 14, 2022
69584-673-10	6958406731069584067310	100 TABLET, FILM COATED in 1 BOTTLE (69584-673-10)Marketed from Nov 14, 2022
69584-673-50	6958406735069584067350	500 TABLET, FILM COATED in 1 BOTTLE (69584-673-50)Marketed from Nov 14, 2022
69584-673-90	6958406739069584067390	1000 TABLET, FILM COATED in 1 BOTTLE (69584-673-90)Marketed from Nov 14, 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): paroxetine hydrochloride
Generic name (nonproprietary): paroxetine hydrochloride
Active ingredients: Paroxetine hydrochloride — 30 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Oxford Pharmaceuticals, LLCNDC labeler code 69584
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076968
Marketing start: Nov 14, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 69584-673_2ac7f06f-af78-4705-a209-d9041b2de825SPL ID 2ac7f06f-af78-4705-a209-d9041b2de825SPL set ID 25182b68-8f7a-48e8-9788-6818b0984b29RxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8
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

N469584067303 followed by a unit qualifier and the quantity

Package 69584-0673-03. 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 Aug 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD) Paroxetine is indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69584-673

What is NDC 69584-673?: 69584-673 is the product NDC for paroxetine hydrochloride, Paroxetine hydrochloride 30 mg/1 tablet, film coated, listed with the FDA by Oxford Pharmaceuticals, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: paroxetine hydrochloride.
What is the active ingredient?: Paroxetine hydrochloride.
Who is the labeler?: Oxford Pharmaceuticals, LLC, NDC labeler code 69584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for paroxetine hydrochloride?: 12 other product NDCs are listed under this name. See all paroxetine hydrochloride 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 paroxetine hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paroxetine Hydrochloride	Paroxetine hydrochloride 10 mg/5mL	SuspensionOral	Camber Pharmaceuticals, Inc.	31722-578	31722-0578-25
paroxetine hydrochloride	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-671	69584-0671-0369584-0671-0969584-0671-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-672	69584-0672-0369584-0672-0969584-0672-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride 40 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-674	69584-0674-0369584-0674-0969584-0674-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9650	71335-9650-0171335-9650-0271335-9650-03+1 more
Paroxetine Hydrochloride	Paroxetine hydrochloride 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Apotex Corp	60505-1316	60505-1316-03
Paroxetine Hydrochloride	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Apotex Corp	60505-1317	60505-1317-03
Paroxetine Hydrochloride	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Apotex Corp	60505-1318	60505-1318-03
Paroxetine Hydrochloride	Paroxetine hydrochloride 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Lannett Company, Inc.	62175-470	62175-0470-3262175-0470-41
Paroxetine Hydrochloride	Paroxetine hydrochloride 25 mg/1	Tablet, Film coated, Extended releaseOral	Lannett Company, Inc.	62175-471	62175-0471-3262175-0471-41

All 13 paroxetine hydrochloride NDCs

Other NDCs under ANDA 076968

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

FDA NDC Directory listings under ANDA 076968
Product	Strength	Form · route	Labeler	Product NDC
paroxetine hydrochloride	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-671
paroxetine hydrochloride	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-672
paroxetine hydrochloride	Paroxetine hydrochloride 40 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-674
paroxetine hydrochloride	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9650