NDC 27241-098 – Duloxetine
Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · Oral
Product NDC27241-098
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 30 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 27241-098-03 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-03) | Mar 16, 2017 |
| 27241-098-09 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-09) | Mar 16, 2017 |
| 27241-098-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-10) | Mar 16, 2017 |
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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