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NDC 80491-7825-02 QUVIVIQ 25 mg/1 Details
QUVIVIQ 25 mg/1
QUVIVIQ is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Idorsia Pharmaceuticals Ltd. The primary component is DARIDOREXANT.
MedlinePlus Drug Summary
Daridorexant is used to treat insomnia (difficulty falling asleep or staying asleep). Daridorexant 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: 80491-7825-02Last Updated: 05/26/2024
MedLinePlus Full Drug Details: Daridorexant
Product Information
| NDC | 80491-7825 |
|---|---|
| Product ID | 80491-7825_4ee2df0f-c9f4-4b59-992c-0c2b838676c7 |
| Associated GPIs | 60500020100320 |
| GCN Sequence Number | 082964 |
| GCN Sequence Number Description | daridorexant HCl TABLET 25 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 51785 |
| HICL Sequence Number | 047751 |
| HICL Sequence Number Description | DARIDOREXANT HCL |
| Brand/Generic | Brand |
| Proprietary Name | QUVIVIQ |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Daridorexant |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DARIDOREXANT |
| Labeler Name | Idorsia Pharmaceuticals Ltd |
| Pharmaceutical Class | Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA] |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA214985 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 80491-7825-02 (80491782502)
| NDC Package Code | 80491-7825-2 |
|---|---|
| Billing NDC | 80491782502 |
| Package | 1 BLISTER PACK in 1 CARTON (80491-7825-2) / 7 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2023-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |