Prescription drug · ANDA
paroxetine hydrochloride NDC 69584-674
Paroxetine hydrochloride 40 mg/1 · Tablet, Film coated · Oral · Oxford Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69584-674-03 | 6958406740369584067403 | 30 TABLET, FILM COATED in 1 BOTTLE (69584-674-03)Marketed from Nov 14, 2022 | |
| 69584-674-09 | 6958406740969584067409 | 90 TABLET, FILM COATED in 1 BOTTLE (69584-674-09)Marketed from Nov 14, 2022 | |
| 69584-674-10 | 6958406741069584067410 | 100 TABLET, FILM COATED in 1 BOTTLE (69584-674-10)Marketed from Nov 14, 2022 | |
| 69584-674-50 | 6958406745069584067450 | 500 TABLET, FILM COATED in 1 BOTTLE (69584-674-50)Marketed from Nov 14, 2022 | |
| 69584-674-90 | 6958406749069584067490 | 1000 TABLET, FILM COATED in 1 BOTTLE (69584-674-90)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 — 40 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
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 69584-674_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
N469584067403followed by a unit qualifier and the quantityPackage 69584-0674-03. 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 . 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.
About NDC 69584-674
- What is NDC 69584-674?
- 69584-674 is the product NDC for paroxetine hydrochloride, Paroxetine hydrochloride 40 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.
Related NDCs: other paroxetine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 30 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-673 | 69584-0673-0369584-0673-0969584-0673-10+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 |
Other NDCs under ANDA 076968
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 30 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-673 |
| paroxetine hydrochloride | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9650 |