Prescription drug · ANDA
Paroxetine Hydrochloride NDC 62175-472
Paroxetine hydrochloride 37.5 mg/1 · Tablet, Film coated, Extended release · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62175-472-32 | 6217504723262175047232 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-472-32)Marketed from Oct 31, 2014 | |
| 62175-472-41 | 6217504724162175047241 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-472-41)Marketed from Oct 31, 2014 |
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 — 37.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Lannett Company, Inc.NDC labeler code 62175
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204744
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 62175-472_9474f942-d6d8-486b-8ea6-f8c561bb5014SPL ID 9474f942-d6d8-486b-8ea6-f8c561bb5014SPL set ID f22886f5-230c-47e4-9dd8-ffb14c8d6ae4RxCUI 1738803, 1738805, 1738807UNII X2ELS050D8UPC 0362175470324
- 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
N462175047232followed by a unit qualifier and the quantityPackage 62175-0472-32. 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 indicated for the treatment of: Major depressive disorder (MDD) in adults Panic disorder (PD) in adults Social anxiety disorder (SAD) in adults Premenstrual dysphoric disorder (PMDD) in adults Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) in adults Panic disorder (PD) in adults Social anxiety disorder (SAD) in adults Premenstrual dysphoric disorder (PMDD) in adults
Excerpt only. Read the full label for complete information.
About NDC 62175-472
- What is NDC 62175-472?
- 62175-472 is the product NDC for Paroxetine Hydrochloride, Paroxetine hydrochloride 37.5 mg/1 tablet, film coated, extended release, listed with the FDA by Lannett Company, Inc.. It has 2 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?
- Lannett Company, Inc., NDC labeler code 62175. 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 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 |
Other NDCs under ANDA 204744
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 | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-425 |
| Paroxetine | Paroxetine hydrochloride 25 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-426 |
| Paroxetine | Paroxetine hydrochloride 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-427 |
| Paroxetine Hydrochloride | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-470 |
| Paroxetine Hydrochloride | Paroxetine hydrochloride 25 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-471 |
| Paroxetine Hydrochloride | Paroxetine hydrochloride hemihydrate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8527 |