Prescription drug · ANDA
Paroxetine (paroxetine hydrochloride hemihydrate) NDC 0378-7002
Paroxetine hydrochloride 20 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7002-10 | 00378700210 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7002-10)Marketed from Mar 24, 2008 | |
| 0378-7002-93 | 00378700293 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7002-93)Marketed from Mar 24, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride hemihydrate
- Active ingredients
- Paroxetine hydrochloride — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078902
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-7002_3e4bd491-25fa-466f-b653-f36241ffde16SPL ID 3e4bd491-25fa-466f-b653-f36241ffde16SPL set ID 89dd7e24-85fc-4152-89ea-47ec2b48a1edRxCUI 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
N400378700210followed by a unit qualifier and the quantityPackage 00378-7002-10. 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 tablets are 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 tablets are 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.
Other NDCs under ANDA 078902
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 |
|---|---|---|---|---|
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-7004 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8777 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-544 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-554 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-037 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-053 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-204 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-243 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-7001 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-7003 |