NDC 82009-031 – Duloxetine
Duloxetine Hydrochloride 40 mg/1 · Capsule, Delayed Release Pellets · Oral
Product NDC82009-031
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
- May 21, 2018
- Listing expires
- December 31, 2026
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
Active ingredients
- Duloxetine Hydrochloride 40 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 82009-031-90 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-031-90) | Jun 1, 2023 |
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.
Other Duloxetine products
- 50090-6889 Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release Pellets · A-S Medication Solutions
- 0228-2890 Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release Pellets · Actavis Pharma, Inc.
- 0228-2891 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release Pellets · Actavis Pharma, Inc.
- 0228-2892 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release Pellets · Actavis Pharma, Inc.
- 71610-743 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release Pellets · Aphena Pharma Solutions - Tennessee, LLC
- 71610-736 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release Pellets · Aphena Pharma Solutions - Tennessee, LLC
- 71610-739 Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release Pellets · Aphena Pharma Solutions - Tennessee, LLC
- 71610-218 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release Pellets · Aphena Pharma Solutions - Tennessee, LLC
- 76420-236 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release Pellets · Asclemed USA, Inc.
- 68001-368 Duloxetine Hydrochloride 40 mg/1 · Capsule, Delayed Release Pellets · BluePoint Laboratories
- 51991-748 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release Pellets · Breckenridge Pharmaceutical, Inc.
- 51991-750 Duloxetine Hydrochloride 40 mg/1 · Capsule, Delayed Release Pellets · Breckenridge Pharmaceutical, Inc.