NDC 76299-322
Stendra
Avanafil
Stendra is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mist Pharmaceuticals, Llc. The primary component is Avanafil.
| Product ID | 76299-322_3e7ad8d2-412c-4253-81f1-cd542ebab45b |
| NDC | 76299-322 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Stendra |
| Generic Name | Avanafil |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-12-27 |
| Marketing Category | NDA / NDA |
| Application Number | NDA202276 |
| Labeler Name | Mist Pharmaceuticals, LLC |
| Substance Name | AVANAFIL |
| Active Ingredient Strength | 200 mg/1 |
| Pharm Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 76299-322-85
30 TABLET in 1 BOTTLE (76299-322-85)
| Marketing Start Date | 2013-12-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 76299-322-01 [76299032201]
Stendra TABLET
| Marketing Category | NDA |
| Application Number | NDA202276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-01-05 |
NDC 76299-322-96 [76299032296]
Stendra TABLET
| Marketing Category | NDA |
| Application Number | NDA202276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-01-01 |
| Inactivation Date | 2020-01-31 |
NDC 76299-322-73 [76299032273]
Stendra TABLET
| Marketing Category | NDA |
| Application Number | NDA202276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-05-10 |
| Marketing End Date | 2018-01-05 |
NDC 76299-322-85 [76299032285]
Stendra TABLET
| Marketing Category | NDA |
| Application Number | NDA202276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-12-27 |
| Inactivation Date | 2020-01-31 |
NDC 76299-322-88 [76299032288]
Stendra TABLET
| Marketing Category | NDA |
| Application Number | NDA202276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-12-27 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| AVANAFIL | 200 mg/1 |
OpenFDA Data
| SPL SET ID: | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Phosphodiesterase 5 Inhibitor [EPC]
- Phosphodiesterase 5 Inhibitors [MoA]
Medicade Reported Pricing
76299032285 STENDRA 200 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Stendra" or generic name "Avanafil"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 62541-501 | STENDRA | Avanafil |
| 62541-502 | STENDRA | Avanafil |
| 62541-503 | STENDRA | Avanafil |
| 72384-751 | Stendra | avanafil |
| 72384-752 | Stendra | avanafil |
| 72384-753 | Stendra | avanafil |
| 76299-320 | Stendra | avanafil |
| 76299-321 | Stendra | avanafil |
| 76299-322 | Stendra | avanafil |
Trademark Results [Stendra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STENDRA 85565411 4526269 Live/Registered |
METUCHEN PHARMACEUTICALS, LLC 2012-03-09 |
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