Paroxetine Hydrochloride
- Product NDC
- 0378-2004
- 11-digit product format
- 003782004
- Labeler code
- 0378
- Product ID
- 0378-2004_c0e82152-59ec-4ca4-8d1a-883ad52f98bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA077873
- Marketing category
- ANDA
- Marketing start
- 2008-05-14
- Marketing end
- 2021-11-30
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ace441e-5ed1-9a56-64e5-302d887093bd | Product name | 7 | 20250107 |
| ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7f | Product name | 4 | 20220524 |
| 200c61bf-0879-1df7-72b7-b72a8497b114 | Product name | 3 | 20171006 |
| b430fc19-562d-420b-53a2-64d42b938631 | Product name | 1 | 20140508 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1738803 | PARoxetine HCl 12.5 MG 24HR Extended Release Oral Tablet | PSN | 21b3b8a2-bfed-4945-954d-6a42ea61888f | 3 |
| 1738805 | PARoxetine HCl 25 MG 24HR Extended Release Oral Tablet | PSN | 21b3b8a2-bfed-4945-954d-6a42ea61888f | 3 |
| 1738803 | 24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet | SCD | 21b3b8a2-bfed-4945-954d-6a42ea61888f | 3 |
| 1738805 | 24 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet | SCD | 21b3b8a2-bfed-4945-954d-6a42ea61888f | 3 |
| 1738803 | paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet | SY | 21b3b8a2-bfed-4945-954d-6a42ea61888f | 3 |
| 1738805 | paroxetine hydrochloride 25 MG 24 HR Extended Release Oral Tablet | SY | 21b3b8a2-bfed-4945-954d-6a42ea61888f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-2004-93 | 00378200493 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2004-93) | 2008-05-14 | 0000-00-00 | No | No | Current |