Prescription drug · ANDA
Paroxetine NDC 13107-155
Paroxetine hydrochloride hemihydrate 20 mg/1 · Tablet, Film coated · Oral · Aurolife Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-155-01 | 13107015501 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-155-01)Marketed from Dec 3, 2009 | |
| 13107-155-05 | 13107015505 | 500 TABLET, FILM COATED in 1 BOTTLE (13107-155-05)Marketed from Dec 3, 2009 | |
| 13107-155-30 | 13107015530 | 30 TABLET, FILM COATED in 1 BOTTLE (13107-155-30)Marketed from Dec 3, 2009 | |
| 13107-155-90 | 13107015590 | 90 TABLET, FILM COATED in 1 BOTTLE (13107-155-90)Marketed from Dec 3, 2009 | |
| 13107-155-99 | 13107015599 | 1000 TABLET, FILM COATED in 1 BOTTLE (13107-155-99)Marketed from Dec 3, 2009 |
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 hemihydrate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurolife Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078406
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 13107-155_c399d3cd-13a5-4493-9a93-c4bf5e2532fcSPL ID c399d3cd-13a5-4493-9a93-c4bf5e2532fcSPL set ID e1ea4019-bb66-403c-a3d5-6ae056a59116RxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8UPC 0313107155307, 0313107154300
- 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
N413107015501followed by a unit qualifier and the quantityPackage 13107-0155-01. 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 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 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.
Other NDCs under ANDA 078406
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 hemihydrate 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-056 |
| Paroxetine | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8359 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-184 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-181 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-182 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-183 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-640 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-642 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-643 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-713 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-154 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-156 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-157 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2574 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-564 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-157 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-154 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-155 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-156 |