Prescription drug · ANDA
Paroxetine (paroxetine hydrochloride hemihydrate) NDC 43547-350
Paroxetine hydrochloride hemihydrate 40 mg/1 · Tablet, Film coated · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)43547-350Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0350Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-350-03 | 43547035003 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-350-03)Marketed from Mar 29, 2022 | |
| 43547-350-09 | 43547035009 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-350-09)Marketed from Mar 29, 2022 | |
| 43547-350-11 | 43547035011 | 1000 TABLET, FILM COATED in 1 BOTTLE (43547-350-11)Marketed from Mar 29, 2022 | |
| 43547-350-50 | 43547035050 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-350-50)Marketed from Mar 29, 2022 |
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 hemihydrate
- Active ingredients
- Paroxetine hydrochloride hemihydrate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- 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 43547-350_48f30016-3f81-4060-887c-6eaf14f17c1cSPL ID 48f30016-3f81-4060-887c-6eaf14f17c1cSPL set ID 6cfde064-ddcb-49df-a53c-953c40eb1470RxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8UPC 0343547350031, 0343547348038, 0343547347031, 0343547349035
- 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
N443547035003followed by a unit qualifier and the quantityPackage 43547-0350-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 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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