SUNOSI
- Product NDC
- 81968-350
- 11-digit product format
- 819680350
- Labeler code
- 81968
- Product ID
- 81968-350_f0a0a507-33cd-4ab1-b438-12996fae6ae1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- solriamfetol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Axsome Therapeutics, Inc.
- Application
- NDA211230
- Marketing category
- NDA
- Marketing start
- 2019-06-18
- Substance
- SOLRIAMFETOL
- Active strength
- 75 mg/1
- Pharmacologic classes
- Dopamine Uptake Inhibitors [MoA], Dopamine and Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SUNOSI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOLRIAMFETOL | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 939U7C91AI |
| Rxcui | 2121756, 2121758, 2121764, 2173841 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81968-350-01 | SUNOSI | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 6 |
| 81968-350-07 | SUNOSI | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 6 |
| 81968-350-10 | SUNOSI | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81968-350 | SUNOSI (SOLRIAMFETOL) TABLET, FILM COATED [AXSOME THERAPEUTICS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20230711_362f206b-73e7-4009-8c34-5a9df55679ab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81968-350-01 | 81968035001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01) | | 2022-06-02 | 0000-00-00 | No | No | Current |
| 81968-350-07 | 81968035007 | 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) | | 2022-06-02 | | Yes | No | Current |
| 81968-350-10 | 81968035010 | 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) | 10 blister pack | 2022-06-02 | 0000-00-00 | Yes | No | Current |