Prescription drug · NDA
Paxil (Paroxetine hydrochloride) NDC 60505-4517
Paroxetine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4517-3 | 6050545170360505451703 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4517-3)Marketed from Mar 11, 2019 |
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)
- Paxil
- Generic name (nonproprietary)
- paroxetine hydrochloride
- Active ingredients
- Paroxetine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020031
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-4517_e1aa474e-4ffe-6c6c-8037-84907819bb88SPL ID e1aa474e-4ffe-6c6c-8037-84907819bb88
- 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
N460505451703followed by a unit qualifier and the quantityPackage 60505-4517-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-4517
- What is NDC 60505-4517?
- 60505-4517 is the product NDC for Paxil (paroxetine hydrochloride), Paroxetine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paxil (Paroxetine hydrochloride).
- What is the active ingredient?
- Paroxetine hydrochloride.
- Who is the labeler?
- Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Paxil?
- 3 other product NDCs are listed under this name. See all Paxil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paxil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paxilparoxetine hydrochloride | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4518 | 60505-4518-03 |
| Paxilparoxetine hydrochloride | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4519 | 60505-4519-03 |
| Paxilparoxetine hydrochloride | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4520 | 60505-4520-03 |
Other NDCs under NDA 020031
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 |
|---|---|---|---|---|
| Paxilparoxetine hydrochloride | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4518 |
| Paxilparoxetine hydrochloride | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4519 |
| Paxilparoxetine hydrochloride | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4520 |