NDC 76420-634 – Duloxetine
Duloxetine Hydrochloride 30 mg/1 · Capsule, Delayed Release · Oral
Product NDC76420-634
Product details
- Brand name
- Duloxetine
- Generic name
- Duloxetine
- Labeler
- Asclemed 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 (6)
| Package NDC | Description | Since |
|---|---|---|
| 76420-634-00 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-00) | Apr 3, 2025 |
| 76420-634-01 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-01) | Oct 17, 2023 |
| 76420-634-20 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-20) | Apr 3, 2025 |
| 76420-634-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-30) | Oct 17, 2023 |
| 76420-634-60 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-60) | Oct 17, 2023 |
| 76420-634-90 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-634-90) | Oct 17, 2023 |
Recalls mentioning this NDC
- D-0555-2026 Jun 10, 2026 · Class II
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
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