Sildenafil
- Product NDC
- 43353-345
- 11-digit product format
- 433530345
- Labeler code
- 43353
- Product ID
- 43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil citrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021845
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-09-27
- 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 |
|---|
| 43353-345-10 | Sildenafil | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 43353-345-20 | Sildenafil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 43353-345-53 | Sildenafil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-345 | SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20170706_761f9606-2583-439a-a29e-736008340a9e.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 |
|---|
| 43353-345-10 | 43353034510 | 10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10) | 2017-07-03 | 0000-00-00 | No | No | Current |
| 43353-345-20 | 43353034520 | 20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20) | 2017-07-03 | 0000-00-00 | No | No | Current |
| 43353-345-53 | 43353034553 | 60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53) | 2017-07-03 | 0000-00-00 | No | No | Current |