Stendra
- Product NDC
- 76299-320
- 11-digit product format
- 762990320
- Labeler code
- 76299
- Product ID
- 76299-320_41d308f4-9a6a-48bb-b7a0-d63da9818078
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- avanafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mist Pharmaceuticals, LLC
- Application
- NDA202276
- Marketing category
- NDA
- Marketing start
- 2013-12-27
- Marketing end
- 0000-00-00
- Substance
- AVANAFIL
- Active strength
- 50 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76299-320-85 | 2023-02-15 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-88 | 2023-02-15 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-85 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-88 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-85 | 2020-07-02 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-88 | 2020-07-02 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-85 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
| 76299-320-88 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-30e5-f424-e053-dadaa90a57ce | a8726f90-9329-46ca-9379-2b50c78fe0e2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76299-320-85 | EA - Each | 76299-320 | 70384a07-f392-4305-8d9c-8fd1261d7e1f | 1 | 2017-08-11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76299-320-85 | 76299032085 | 30 TABLET in 1 BOTTLE (76299-320-85) | 30 tablet | 2013-12-27 | 0000-00-00 | No | No | Current |