NDC 0006-0005 – Belsomra
Suvorexant 5 mg/1 · Tablet, Film Coated · Oral
Product NDC0006-0005
Product details
- Brand name
- Belsomra
- Generic name
- Suvorexant
- Labeler
- Merck Sharp & Dohme LLC
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA204569
- Marketed since
- August 29, 2014
- Listing expires
- December 31, 2026
- Pharmacologic class
- Orexin Receptor Antagonist
Active ingredients
- Suvorexant 5 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0006-0005-13 | 1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK | Aug 29, 2014 |
| 0006-0005-30 | 3 CASE in 1 CARTON (0006-0005-30) / 1 BLISTER PACK in 1 CASE (0006-0005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | Aug 29, 2014 |
Recalls mentioning this NDC
- D-0584-2025 Aug 20, 2025 · Class II
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep. - D-0523-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.