SILDENAFIL
- Product NDC
- 76282-643
- 11-digit product format
- 762820643
- Labeler code
- 76282
- Product ID
- 76282-643_2feb2e90-dc79-4542-87c5-42653c624704
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA207178
- Marketing category
- ANDA
- Marketing start
- 2022-07-01
- Substance
- SILDENAFIL CITRATE
- Active strength
- 25 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 | 25 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 |
|---|
| 76282-643-30 | SILDENAFIL | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-643 | SILDENAFIL TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20220811_1883785c-a1a4-48fe-b722-afacf2875ca8.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 |
|---|
| 76282-643-01 | 76282064301 | 30 TABLET in 1 BOTTLE (76282-643-01) | 30 tablet | 2022-07-01 | 0000-00-00 | No | No | Current |
| 76282-643-30 | 76282064330 | 30 TABLET in 1 BOTTLE (76282-643-30) | 30 tablet | 2022-07-01 | 0000-00-00 | No | No | Current |