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NDC 81968-0350-10 SUNOSI 75 mg/1 Details
SUNOSI 75 mg/1
SUNOSI is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Axsome Therapeutics, Inc.. The primary component is SOLRIAMFETOL.
MedlinePlus Drug Summary
Solriamfetol is used to treat excessive daytime sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness). Solriamfetol is also used along with breathing devices or other treatments to prevent excessive daytime sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore doesn't get enough restful sleep). Solriamfetol is in a class of medications called wakefulness promoting agents. It works by increasing the amounts of certain natural substances in the brain that controls sleep and wakefulness.
Related Packages: 81968-0350-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Solriamfetol
Product Information
| NDC | 81968-0350 |
|---|---|
| Product ID | 81968-350_675fa3ba-cafd-496b-8820-ab42b4e95df8 |
| Associated GPIs | |
| GCN Sequence Number | 079597 |
| GCN Sequence Number Description | solriamfetol HCl TABLET 75 MG ORAL |
| HIC3 | H8Q |
| HIC3 Description | NARCOLEPSY AND SLEEP DISORDER THERAPY AGENTS |
| GCN | 46126 |
| HICL Sequence Number | 045666 |
| HICL Sequence Number Description | SOLRIAMFETOL HCL |
| Brand/Generic | Brand |
| Proprietary Name | SUNOSI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | solriamfetol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 75 |
| Active Ingredient Units | mg/1 |
| Substance Name | SOLRIAMFETOL |
| Labeler Name | Axsome Therapeutics, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA211230 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 81968-0350-10 (81968035010)
| NDC Package Code | 81968-350-10 |
|---|---|
| Billing NDC | 81968035010 |
| Package | 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) |
| Marketing Start Date | 2022-06-02 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 27.7903 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | SUNOSI 75 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |