MOVANTIK is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Redhill Biopharma Ltd. The primary component is Naloxegol Oxalate.
| Product ID | 57841-1300_046d2fd8-3056-425f-a196-7ff77450368c |
| NDC | 57841-1300 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MOVANTIK |
| Generic Name | Naloxegol Oxalate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-10-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204760 |
| Labeler Name | RedHill Biopharma Ltd |
| Substance Name | NALOXEGOL OXALATE |
| Active Ingredient Strength | 13 mg/1 |
| Pharm Classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2020-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-1969 | MOVANTIK | naloxegol oxalate |
| 0310-1970 | MOVANTIK | naloxegol oxalate |
| 55700-383 | MOVANTIK | naloxegol oxalate |
| 55700-988 | MOVANTIK | naloxegol oxalate |
| 57841-1300 | MOVANTIK | naloxegol oxalate |
| 57841-1301 | MOVANTIK | naloxegol oxalate |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MOVANTIK 86205691 4782846 Live/Registered |
AstraZeneca AB 2014-02-27 |
![]() MOVANTIK 86089235 4600146 Live/Registered |
AstraZeneca AB 2013-10-11 |