NDC 27241-097 – Duloxetine
Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release · Oral
Product NDC27241-097
Product details
- Brand name
- Duloxetine
- Generic name
- Duloxetine
- Labeler
- Ajanta Pharma USA Inc.
- Dosage form
- Capsule, Delayed Release
- Route
- Oral
- Marketing category
- ANDA · ANDA208706
- Marketed since
- March 16, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
Active ingredients
- Duloxetine Hydrochloride 20 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 27241-097-05 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-05) | Oct 18, 2021 |
| 27241-097-06 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-06) | Mar 16, 2017 |
| 27241-097-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-10) | Mar 16, 2017 |
| 27241-097-90 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-90) | Oct 18, 2021 |
Recalls mentioning this NDC
- D-0514-2026 May 13, 2026 · Class II
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. - D-0516-2026 May 13, 2026 · Class II
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. - D-0515-2026 May 13, 2026 · Class II
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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