Prescription drug · ANDA
Paroxetine Hydrochloride NDC 63629-8527
Paroxetine hydrochloride hemihydrate 25 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8527-1 | 63629852701 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)Marketed from Oct 31, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hemihydrate — 25 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37SPL ID d72b03fa-f81e-4eab-95aa-00c6c48ebf37SPL set ID 5e47c4fb-6070-4cb4-acaa-c6e90199b55cRxCUI 1738805UNII 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
N463629852701followed by a unit qualifier and the quantityPackage 63629-8527-01. 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 | 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 | 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 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-472 |