Prescription drug · ANDA
Paroxetine (paroxetine hydrochloride) NDC 67544-492
Paroxetine hydrochloride anhydrous 40 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67544-492-15 | 67544049215 | 15 TABLET, FILM COATED in 1 BOTTLE (67544-492-15)Marketed from Jul 10, 2018 | |
| 67544-492-30 | 67544049230 | 30 TABLET, FILM COATED in 1 BOTTLE (67544-492-30)Marketed from Jul 10, 2018 | |
| 67544-492-45 | 67544049245 | 45 TABLET, FILM COATED in 1 BOTTLE (67544-492-45)Marketed from Jul 10, 2018 |
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 hydrochloride
- Active ingredients
- Paroxetine hydrochloride anhydrous — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075356
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 67544-492_1bb37fe5-45ba-4f89-b480-35fa1dedf247SPL ID 1bb37fe5-45ba-4f89-b480-35fa1dedf247SPL set ID a7128be7-7023-40c4-aa64-29d52145ae31RxCUI 1738511UNII 3I3T11UD2S
- 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
N467544049215followed by a unit qualifier and the quantityPackage 67544-0492-15. 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)
INDICATIONS AND USAGE Major Depressive Disorder Paroxetine tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY, Clinical Trials ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075356
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 | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7999 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0993 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-737 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-734 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-735 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-736 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5676 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1460 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5677 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0083 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0084 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0101 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0097 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-317 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2871 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-992 |