Prescription drug · ANDA
Paroxetine NDC 62135-427
Paroxetine hydrochloride 37.5 mg/1 · Tablet, Film coated, Extended release · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-427-30 | 62135042730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-427-30)Marketed from Dec 5, 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
- Generic name (nonproprietary)
- paroxetine
- Active ingredients
- Paroxetine hydrochloride — 37.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- 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 62135-427_efb6b453-333a-211d-e053-2995a90ae2d9SPL ID efb6b453-333a-211d-e053-2995a90ae2d9SPL set ID 52c3c5c4-6434-4f95-b5f0-9ecfdc0a7e0aRxCUI 1738803, 1738805, 1738807UNII X2ELS050D8UPC 0362135426309, 0362135425302, 0362135427306
- 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
N462135042730followed by a unit qualifier and the quantityPackage 62135-0427-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Paroxetine is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine is 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.
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 Hydrochloride | Paroxetine hydrochloride hemihydrate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8527 |
| Paroxetine | Paroxetine hydrochloride 25 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-426 |
| Paroxetine | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-425 |
| 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 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-472 |