Prescription drug · ANDA
Paroxetine NDC 68180-647
Paroxetine hydrochloride hemihydrate 12.5 mg/1 · Tablet, Film coated, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68180-647Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0647Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Paroxetine
- Generic name (nonproprietary)
- paroxetine
- Active ingredients
- Paroxetine hydrochloride hemihydrate — 12.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204134
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6SPL ID 1a9bc25c-db83-42a0-851a-30212ee10cc6SPL set ID d315e0da-f829-408b-be5d-2bca2e06913cRxCUI 1738803, 1738805, 1738807UNII 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.
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 204134
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 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-645 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-646 |