NDC 68462-391 – Esomeprazole Magnesium
Esomeprazole Magnesium 40 mg/1 · Capsule, Delayed Release Pellets · Oral
Product NDC68462-391
Product details
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Capsule, Delayed Release Pellets
- Route
- Oral
- Marketing category
- ANDA · ANDA209495
- Marketed since
- November 1, 2021
- Listing expires
- December 31, 2026
- Pharmacologic class
- Proton Pump Inhibitor
Active ingredients
- Esomeprazole Magnesium 40 mg/1
Uses, dosage, side effects and warnings for Esomeprazole Magnesium →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 68462-391-10 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-10) | Nov 1, 2021 |
| 68462-391-30 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-30) | Nov 1, 2021 |
| 68462-391-90 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-90) | Nov 1, 2021 |
Recalls mentioning this NDC
- D-0112-2024 Nov 29, 2023 · Class III
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study…
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