NDC 13668-443 – Fluoxetine
Fluoxetine Hydrochloride 10 mg/1 · Tablet · Oral
Product NDC13668-443
Product details
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Labeler
- Torrent Pharmaceuticals Limited
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA206937
- Marketed since
- October 21, 2016
- Listing expires
- December 31, 2026
- Pharmacologic class
- Serotonin Reuptake Inhibitor
Active ingredients
- Fluoxetine Hydrochloride 10 mg/1
Package NDC codes (5)
| Package NDC | Description | Since |
|---|---|---|
| 13668-443-01 | 100 TABLET in 1 BOTTLE (13668-443-01) | Oct 21, 2016 |
| 13668-443-10 | 1000 TABLET in 1 BOTTLE (13668-443-10) | Oct 21, 2016 |
| 13668-443-30 | 30 TABLET in 1 BOTTLE (13668-443-30) | Oct 21, 2016 |
| 13668-443-74 | 100 TABLET in 1 CARTON (13668-443-74) | Oct 21, 2016 |
| 13668-443-91 | 28 TABLET in 1 CARTON (13668-443-91) | Oct 21, 2016 |
Recalls mentioning this NDC
- D-0455-2025 Jun 11, 2025 · Class II
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. - D-0456-2025 Jun 11, 2025 · Class II
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
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