Prescription drug · ANDA
Paroxetine Hydrochloride NDC 31722-578
Paroxetine hydrochloride 10 mg/5mL · Suspension · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-578-25 | 3172205782531722057825 | 1 BOTTLE in 1 CARTON (31722-578-25) / 250 mL in 1 BOTTLEMarketed from Mar 5, 2026 |
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 — 10 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219954
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-578_5092043a-0e8c-05e1-e063-6394a90ad3dcSPL ID 5092043a-0e8c-05e1-e063-6394a90ad3dcSPL set ID 26d37a39-1c53-461c-8834-c67fbffcfe99RxCUI 312242UNII X2ELS050D8UPC 0331722578257
- 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
N431722057825followed by a unit qualifier and the quantityPackage 31722-0578-25. 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 oral suspension 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) 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)
Excerpt only. Read the full label for complete information.
About NDC 31722-578
- What is NDC 31722-578?
- 31722-578 is the product NDC for Paroxetine Hydrochloride, Paroxetine hydrochloride 10 mg/5mL suspension, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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/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 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 |