SILDENAFIL
- Product NDC
- 52817-341
- 11-digit product format
- 528170341
- Labeler code
- 52817
- Product ID
- 52817-341_294da798-e782-4269-e063-6394a90a4b35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TruPharma LLC
- Application
- ANDA204882
- Marketing category
- ANDA
- Marketing start
- 2018-07-01
- Substance
- SILDENAFIL CITRATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SILDENAFIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILDENAFIL CITRATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BW9B0ZE037 |
| Rxcui | 312950, 314228, 314229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-341-10 | SILDENAFIL | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 52817-341-30 | SILDENAFIL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-341 | SILDENAFIL TABLET, FILM COATED [TRUPHARMA LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241217_53078688-ad66-4bb2-808c-b76acedd00e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52817-341-10 | 52817034110 | 100 TABLET, FILM COATED in 1 BOTTLE (52817-341-10) | 2018-07-01 | 0000-00-00 | No | No | Current |
| 52817-341-30 | 52817034130 | 30 TABLET, FILM COATED in 1 BOTTLE (52817-341-30) | 2018-07-01 | 0000-00-00 | No | No | Current |