NDC 27241-164 – Duloxetine
Duloxetine Hydrochloride 40 mg/1 · Capsule, Delayed Release · Oral
Product NDC27241-164
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 25, 2019
- 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 |
|---|---|---|
| 27241-164-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-164-30) | Mar 25, 2019 |
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.
Other Duloxetine products
- 50090-7812 Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-6899 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-7784 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-6893 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-6900 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-5940 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-6775 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-6281 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-6406 Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 50090-7897 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release · A-S Medication Solutions
- 80425-0441 Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · Advanced Rx of Tennessee, LLC
- 80425-0389 Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release · Advanced Rx of Tennessee, LLC