Sildenafil
- Product NDC
- 53746-351
- 11-digit product format
- 537460351
- Labeler code
- 53746
- Product ID
- 53746-351_7548032b-9e89-4c6e-996c-f5ccc07a74d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA202025
- Marketing category
- ANDA
- Marketing start
- 2012-11-08
- Substance
- SILDENAFIL CITRATE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BW9B0ZE037 |
| Rxcui | 577033 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-351-90 | Sildenafil | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-351 | SILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 1 | Current NDC, 1 package rows | 20240730_a0b734f4-9347-484d-b307-d493ae50ee54.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-351-90 | 53746035190 | 90 TABLET in 1 BOTTLE (53746-351-90) | 90 tablet | 2012-11-08 | No | No | Historical |