SILDENAFIL CITRATE
- Product NDC
- 75834-241
- 11-digit product format
- 758340241
- Labeler code
- 75834
- Product ID
- 75834-241_506bb4eb-697e-9d05-e063-6294a90a8f2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL CITRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.
- Application
- ANDA209302
- Marketing category
- ANDA
- Marketing start
- 2020-09-04
- Substance
- SILDENAFIL CITRATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SILDENAFIL CITRATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILDENAFIL CITRATE | 100 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 |
|---|
| 75834-241-00 | SILDENAFIL CITRATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 14 |
| 75834-241-01 | SILDENAFIL CITRATE | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 75834-241-05 | SILDENAFIL CITRATE | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
| 75834-241-30 | SILDENAFIL CITRATE | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-241 | SILDENAFIL CITRATE TABLET [NIVAGEN PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241225_5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-241-00 | 75834024100 | 1000 TABLET in 1 BOTTLE (75834-241-00) | 1000 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |
| 75834-241-01 | 75834024101 | 100 TABLET in 1 BOTTLE (75834-241-01) | 100 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |
| 75834-241-05 | 75834024105 | 500 TABLET in 1 BOTTLE (75834-241-05) | 500 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |
| 75834-241-30 | 75834024130 | 30 TABLET in 1 BOTTLE (75834-241-30) | 30 tablet | 2020-09-04 | 0000-00-00 | No | No | Current |