NDC 68727-351
SUNOSI
Solriamfetol
SUNOSI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Solriamfetol.
| Product ID | 68727-351_34e0a7d5-0967-4fcb-9f90-0c2c7facc3ca |
| NDC | 68727-351 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SUNOSI |
| Generic Name | Solriamfetol |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-06-18 |
| Marketing Category | NDA / NDA |
| Application Number | NDA211230 |
| Labeler Name | Jazz Pharmaceuticals, Inc. |
| Substance Name | SOLRIAMFETOL |
| Active Ingredient Strength | 150 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 68727-351-01
30 TABLET, FILM COATED in 1 BOTTLE (68727-351-01)
| Marketing Start Date | 2019-06-18 |
| Marketing End Date | 2025-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 68727-351-07 [68727035107]
SUNOSI TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA211230 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-06-18 |
NDC 68727-351-01 [68727035101]
SUNOSI TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA211230 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-06-18 |
NDC 68727-351-02 [68727035102]
SUNOSI TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA211230 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-06-18 |
NDC 68727-351-10 [68727035110]
SUNOSI TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA211230 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-06-18 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SOLRIAMFETOL | 150 mg/1 |
OpenFDA Data
| SPL SET ID: | 2f30ab12-20e1-4391-9359-24b23a21578d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "SUNOSI" or generic name "Solriamfetol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68727-350 | SUNOSI | solriamfetol |
| 68727-351 | SUNOSI | solriamfetol |
| 81968-350 | SUNOSI | solriamfetol |
| 81968-351 | SUNOSI | solriamfetol |
Trademark Results [SUNOSI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUNOSI 87151190 5857817 Live/Registered |
Jazz Pharmaceuticals, Inc. 2016-08-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.