Prescription drug · ANDA
Paroxetine (paroxetine hydrochloride hemihydrate) NDC 72162-2358
Paroxetine hydrochloride hemihydrate 40 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2358-9 | 72162235809 | 90 TABLET, FILM COATED in 1 BOTTLE (72162-2358-9)Marketed from Jun 28, 2024 |
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
- Bryant Ranch Prepack
- 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 72162-2358_c6a22c4a-3353-418e-8cda-6cf6b46f3544SPL ID c6a22c4a-3353-418e-8cda-6cf6b46f3544SPL set ID ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0fRxCUI 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
N472162235809followed by a unit qualifier and the quantityPackage 72162-2358-09. 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 Tablets 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, psy…
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 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1253 |
| 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 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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