Prescription drug · ANDA
Paroxetine (paroxetine hydrochloride hemihydrate) NDC 70518-1253
Paroxetine hydrochloride hemihydrate 40 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1253-1 | 70518125301 | 30 POUCH in 1 BOX (70518-1253-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1253-2)Marketed from Jan 14, 2022 | |
| 70518-1253-3 | 70518125303 | 50 POUCH in 1 BOX (70518-1253-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1253-2)Marketed from Jul 20, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hemihydrate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203854
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-1253_570f92fa-5fdb-f026-e063-6294a90a975aSPL ID 570f92fa-5fdb-f026-e063-6294a90a975aSPL set ID 22174520-4b78-4841-96f7-530ba12d2cf1RxCUI 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
N470518125301followed by a unit qualifier and the quantityPackage 70518-1253-01. 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 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 203854
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 hemihydrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3843 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5987 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8829 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2376 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2387 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-379 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7985 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1406 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5304 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2182 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-420 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-198 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2598 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2358 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-348 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-347 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-349 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-350 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-527 |
| Paroxetine | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8173 |
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