NDC 82009-032 – Duloxetine
Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release Pellets · Oral
Product NDC82009-032
Product details
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Labeler
- Quallent Pharmaceuticals Health, LLC
- Dosage form
- Capsule, Delayed Release Pellets
- Route
- Oral
- Marketing category
- ANDA · ANDA203088
- Marketed since
- June 11, 2014
- Listing expires
- December 31, 2026
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
Active ingredients
- Duloxetine Hydrochloride 60 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 82009-032-10 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-032-10) | Dec 15, 2022 |
Recalls mentioning this NDC
- D-0215-2026 Dec 10, 2025 · Class II
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - D-0621-2025 Sep 17, 2025 · Class II
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. - D-0580-2025 Aug 20, 2025 · Class II
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
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