NDC 68382-848 – Esomeprazole Magnesium
Esomeprazole Magnesium Dihydrate 20 mg/1 · Granule, Delayed Release · Oral
Product NDC68382-848
Product details
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Dosage form
- Granule, Delayed Release
- Route
- Oral
- Marketing category
- ANDA · ANDA206055
- Marketed since
- June 30, 2023
- Listing expires
- December 31, 2026
- Pharmacologic class
- Proton Pump Inhibitor
Active ingredients
- Esomeprazole Magnesium Dihydrate 20 mg/1
Uses, dosage, side effects and warnings for Esomeprazole Magnesium →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 68382-848-94 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-848-94) | Jun 30, 2023 |
Recalls mentioning this NDC
- D-0442-2025 May 28, 2025 · Class II
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. - D-0443-2025 May 28, 2025 · Class II
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. - D-0102-2025 Dec 11, 2024 · Class III
Labeling: Not Elsewhere Classified - Wrong NDC number
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- 59651-804 Esomeprazole Magnesium Trihydrate 20 mg/1 · Granule, Delayed Release · Aurobindo Pharma Limited
- 13668-547 Esomeprazole Magnesium 5 mg/1 · Granule, Delayed Release · Torrent Pharmaceuticals Limited
- 13668-548 Esomeprazole Magnesium 10 mg/1 · Granule, Delayed Release · Torrent Pharmaceuticals Limited
- 13668-549 Esomeprazole Magnesium 20 mg/1 · Granule, Delayed Release · Torrent Pharmaceuticals Limited
- 13668-546 Esomeprazole Magnesium 2.5 mg/1 · Granule, Delayed Release · Torrent Pharmaceuticals Limited
- 13668-550 Esomeprazole Magnesium 40 mg/1 · Granule, Delayed Release · Torrent Pharmaceuticals Limited
- 70771-1391 Esomeprazole Magnesium Dihydrate 20 mg/1 · Granule, Delayed Release · Zydus Lifesciences Limited
- 70771-1392 Esomeprazole Magnesium Dihydrate 40 mg/1 · Granule, Delayed Release · Zydus Lifesciences Limited
- 68382-849 Esomeprazole Magnesium Dihydrate 40 mg/1 · Granule, Delayed Release · Zydus Pharmaceuticals USA Inc.