NDC 59011-523
Symproic
Naldemedine
Symproic is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Purdue Pharma Lp. The primary component is Naldemedine Tosylate.
| Product ID | 59011-523_047e56f4-ae1e-db19-b920-79fcbd105aef |
| NDC | 59011-523 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Symproic |
| Generic Name | Naldemedine |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-03-23 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208854 |
| Labeler Name | Purdue Pharma LP |
| Substance Name | NALDEMEDINE TOSYLATE |
| Active Ingredient Strength | 0 mg/1 |
| Pharm Classes | Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 59011-523-30
30 TABLET in 1 BOTTLE (59011-523-30)
| Marketing Start Date | 2018-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59011-523-07 [59011052307]
Symproic TABLET
| Marketing Category | NDA |
| Application Number | NDA208854 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-03-27 |
| Marketing End Date | 2020-12-31 |
NDC 59011-523-30 [59011052330]
Symproic TABLET
| Marketing Category | NDA |
| Application Number | NDA208854 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-04-01 |
| Marketing End Date | 2020-12-31 |
NDC 59011-523-90 [59011052390]
Symproic TABLET
| Marketing Category | NDA |
| Application Number | NDA208854 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-23 |
| Marketing End Date | 2020-12-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| NALDEMEDINE TOSYLATE | .2 mg/1 |
OpenFDA Data
| SPL SET ID: | 6354a7d9-680d-6f6b-97aa-1d3179680e67 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Opioid Antagonist [EPC]
- Opioid Antagonists [MoA]
Medicade Reported Pricing
59011052390 SYMPROIC 0.2 MG TABLET
Pricing Unit: EA | Drug Type:
59011052330 SYMPROIC 0.2 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Symproic" or generic name "Naldemedine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59011-523 | Symproic | naldemedine |
| 59385-041 | SYMPROIC | naldemedine tosylate |
| 59630-222 | SYMPROIC | naldemedine |
Trademark Results [Symproic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMPROIC 79168243 4887392 Live/Registered |
SHIONOGI & CO., LTD. 2015-01-27 |
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