NDC 0591-2245 – Mesalamine
Mesalamine 1.2 g/1 · Tablet, Delayed Release · Oral
Product NDC0591-2245
Product details
- Brand name
- Mesalamine
- Generic name
- Mesalamine
- Labeler
- Actavis Pharma, Inc.
- Dosage form
- Tablet, Delayed Release
- Route
- Oral
- Marketing category
- ANDA · ANDA203817
- Marketed since
- March 26, 2018
- Listing expires
- December 31, 2026
- Pharmacologic class
- Aminosalicylate
Active ingredients
- Mesalamine 1.2 g/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0591-2245-22 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2245-22) | Mar 26, 2018 |
Recalls mentioning this NDC
- D-0069-2021 Nov 18, 2020 · Class II
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. - D-0862-2020 Mar 11, 2020 · Class II
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
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