Sildenafil
- Product NDC
- 68001-597
- 11-digit product format
- 680010597
- Labeler code
- 68001
- Product ID
- 68001-597_28da809a-99b6-e220-e063-6294a90ac8ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA203814
- Marketing category
- ANDA
- Marketing start
- 2023-06-12
- 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 |
|---|
| 68001-597-05 | Sildenafil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-597 | SILDENAFIL TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 10 | Current NDC, 1 package rows | 20241213_be6d1015-306d-44fb-8d4d-01724b8d9590.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-597-05 | 68001059705 | 90 TABLET, FILM COATED in 1 BOTTLE (68001-597-05) | 2023-06-12 | No | No | Current |