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NDC 00006-0005-13 BELSOMRA 5 mg/1 Details
BELSOMRA 5 mg/1
BELSOMRA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is SUVOREXANT.
MedlinePlus Drug Summary
Suvorexant is used treat insomnia (difficulty falling asleep or staying asleep). Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness.
Related Packages: 00006-0005-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Suvorexant
Product Information
| NDC | 00006-0005 |
|---|---|
| Product ID | 0006-0005_18f09198-23e9-48c9-8426-e39828d75ad8 |
| Associated GPIs | 60500070000305 |
| GCN Sequence Number | 072690 |
| GCN Sequence Number Description | suvorexant TABLET 5 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 36967 |
| HICL Sequence Number | 041333 |
| HICL Sequence Number Description | SUVOREXANT |
| Brand/Generic | Brand |
| Proprietary Name | BELSOMRA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | suvorexant |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | SUVOREXANT |
| Labeler Name | Merck Sharp & Dohme LLC |
| Pharmaceutical Class | Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA204569 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00006-0005-13 (00006000513)
| NDC Package Code | 0006-0005-13 |
|---|---|
| Billing NDC | 00006000513 |
| Package | 1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2014-08-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |