NDC 0904-7253 – Dabigatran Etexilate
Dabigatran Etexilate Mesylate 75 mg/1 · Capsule, Coated Pellets · Oral
Product NDC0904-7253
Product details
- Brand name
- Dabigatran Etexilate
- Generic name
- Dabigatran Etexilate
- Labeler
- Major Pharmaceuticals
- Dosage form
- Capsule, Coated Pellets
- Route
- Oral
- Marketing category
- ANDA · ANDA208040
- Marketed since
- June 23, 2025
- Listing expires
- December 31, 2026
- Pharmacologic class
- Direct Thrombin Inhibitor
Active ingredients
- Dabigatran Etexilate Mesylate 75 mg/1
Uses, dosage, side effects and warnings for Dabigatran Etexilate →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0904-7253-04 | 3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) | Jun 23, 2025 |
| 0904-7253-68 | 6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) | Jun 23, 2025 |
Recalls mentioning this NDC
- D-0737-2026 Aug 5, 2026 · Class III
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - D-0738-2026 Aug 5, 2026 · Class III
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - D-0739-2026 Aug 5, 2026 · Class III
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - D-0735-2026 Jul 29, 2026 · Class III
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month… - D-0736-2026 Jul 29, 2026 · Class III
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month…
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