Prescription drug · ANDA
Paroxetine NDC 76420-717
Paroxetine hydrochloride hemihydrate 20 mg/1 · Tablet, Film coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-717-01 | 76420071701 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-717-01)Marketed from May 6, 2024 | |
| 76420-717-05 | 76420071705 | 500 TABLET, FILM COATED in 1 BOTTLE (76420-717-05)Marketed from May 6, 2024 | |
| 76420-717-10 | 76420071710 | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-717-10)Marketed from May 6, 2024 | |
| 76420-717-30 | 76420071730 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-717-30)Marketed from May 6, 2024 | |
| 76420-717-60 | 76420071760 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-717-60)Marketed from May 6, 2024 | |
| 76420-717-90 | 76420071790 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-717-90)Marketed from May 6, 2024 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077584
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-717_2e000f86-0592-a362-e063-6394a90a169dSPL ID 2e000f86-0592-a362-e063-6394a90a169dSPL set ID 4acd3e7a-4f19-4428-9452-48ce370cb3dbRxCUI 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
N476420071701followed by a unit qualifier and the quantityPackage 76420-0717-01. 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 077584
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 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0321 |
| Paroxetine | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-6870 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3349 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0446 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc | 68788-0797 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-716 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-718 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-719 |
| Paroxetine | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0850 |
| Paroxetine | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7410 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-492 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-001 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0544 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | DIRECT RX | 61919-513 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-434 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2465 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3430 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc | 68788-9074 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0846 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-097 |
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