NDC 51991-748 – Duloxetine Delayed-Release
Duloxetine Hydrochloride 60 mg/1 · Capsule, Delayed Release Pellets · Oral
Product NDC51991-748
Product details
- Brand name
- Duloxetine Delayed-Release
- Generic name
- Duloxetine Hydrochloride
- Labeler
- Breckenridge Pharmaceutical, Inc.
- 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 (3)
| Package NDC | Description | Since |
|---|---|---|
| 51991-748-10 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-748-10) | Jun 11, 2014 |
| 51991-748-33 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-748-33) | Jun 11, 2014 |
| 51991-748-90 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-748-90) | Jun 11, 2014 |
Recalls mentioning this NDC
- D-0582-2026 Jun 17, 2026 · Class II
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - D-0583-2026 Jun 17, 2026 · Class II
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - D-0522-2026 May 13, 2026 · Class II
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - D-0216-2026 Dec 10, 2025 · Class II
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - D-0100-2026 Nov 5, 2025 · Class II
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. - D-0552-2025 Aug 13, 2025 · Class II
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit - D-0511-2025 Jul 16, 2025 · Class II
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - D-0388-2025 Apr 30, 2025 · Class II
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - D-0387-2025 Apr 30, 2025 · Class II
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - D-0308-2025 Apr 9, 2025 · Class II
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
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- 68001-368 Duloxetine Hydrochloride 40 mg/1 · Capsule, Delayed Release Pellets · BluePoint Laboratories
- 51991-750 Duloxetine Hydrochloride 40 mg/1 · Capsule, Delayed Release Pellets · Breckenridge Pharmaceutical, Inc.
- 51991-746 Duloxetine Hydrochloride 20 mg/1 · Capsule, Delayed Release Pellets · Breckenridge Pharmaceutical, Inc.