NDC 60505-0097 – Paroxetine
Paroxetine Hydrochloride Anhydrous 10 mg/1 · Tablet, Film Coated · Oral
Product NDC60505-0097
Product details
- Brand name
- Paroxetine
- Generic name
- Paroxetine hydrochloride
- Labeler
- Apotex Corp.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA075356
- Marketed since
- September 8, 2003
- Listing expires
- December 31, 2027
- Pharmacologic class
- Serotonin Reuptake Inhibitor
Active ingredients
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 60505-0097-1 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-0097-1) | Sep 8, 2003 |
| 60505-0097-2 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-0097-2) | Sep 8, 2003 |
| 60505-0097-4 | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0097-4) | Sep 8, 2003 |
Recalls mentioning this NDC
- D-0119-2024 Dec 6, 2023 · Class II
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - D-0120-2024 Dec 6, 2023 · Class II
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - D-0121-2024 Dec 6, 2023 · Class II
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - D-0122-2024 Dec 6, 2023 · Class II
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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