Prescription drug · ANDA
Paroxetine NDC 50268-643
Paroxetine hydrochloride hemihydrate 40 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-643-15 | 50268064315 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-643-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-643-11)Marketed from Mar 11, 2016 |
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 — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvPAK
- 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 50268-643_4dc86e5a-77b7-8cfe-e063-6394a90a7289SPL ID 4dc86e5a-77b7-8cfe-e063-6394a90a7289SPL set ID d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43RxCUI 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
N450268064315followed by a unit qualifier and the quantityPackage 50268-0643-15. 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, USP 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, psychom…
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 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 20 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-155 |
| 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 |