Prescription drug · NDA
Paxil CR (Paroxetine hydrochloride) NDC 60505-4379
Paroxetine hydrochloride 37.5 mg/1 · Tablet, Film coated, Extended release · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4379-3 | 6050543790360505437903 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4379-3)Marketed from Jan 1, 2011 |
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 CRSuffix: CR
- Generic name (nonproprietary)
- paroxetine hydrochloride
- Active ingredients
- Paroxetine hydrochloride — 37.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020936
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-4379_537a5f05-8311-a97e-acde-275206595dcdSPL ID 537a5f05-8311-a97e-acde-275206595dcd
- 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
N460505437903followed by a unit qualifier and the quantityPackage 60505-4379-03. 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 60505-4379
- What is NDC 60505-4379?
- 60505-4379 is the product NDC for Paxil CR (paroxetine hydrochloride), Paroxetine hydrochloride 37.5 mg/1 tablet, film coated, extended release, 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 CR (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 CR?
- 2 other product NDCs are listed under this name. See all Paxil CR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paxil CR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paxil CRparoxetine hydrochloride | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-4377 | 60505-4377-03 |
| Paxil CRparoxetine hydrochloride | Paroxetine hydrochloride 25 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-4378 | 60505-4378-03 |
Other NDCs under NDA 020936
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 Hydrochloride | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-1316 |
| Paroxetine Hydrochloride | Paroxetine hydrochloride hemihydrate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-1317 |
| Paroxetine Hydrochloride | Paroxetine hydrochloride hemihydrate 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-1318 |
| Paxil CRparoxetine hydrochloride | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-4377 |
| Paxil CRparoxetine hydrochloride | Paroxetine hydrochloride 25 mg/1 | Tablet, Film coated, Extended releaseOral | Apotex Corp | 60505-4378 |