SILDENAFIL CITRATE
- Product NDC
- 76420-613
- 11-digit product format
- 764200613
- Labeler code
- 76420
- Product ID
- 76420-613_05373fec-0f63-7fd4-e063-6394a90af72d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL CITRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA091479
- Marketing category
- ANDA
- Marketing start
- 2012-11-06
- 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 CITRATE
- 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 |
|---|
| 76420-613-30 | SILDENAFIL CITRATE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 76420-613-60 | SILDENAFIL CITRATE | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 76420-613-90 | SILDENAFIL CITRATE | 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 |
|---|
| 76420-613 | SILDENAFIL CITRATE TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, 3 package rows | 20230914_49a95b25-08b3-4cfe-a60b-c5132c280be2.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 |
|---|
| 76420-613-30 | 76420061330 | 30 TABLET in 1 BOTTLE (76420-613-30) | 30 tablet | 2023-09-13 | No | No | Current |
| 76420-613-60 | 76420061360 | 60 TABLET in 1 BOTTLE (76420-613-60) | 60 tablet | 2023-09-13 | No | No | Current |
| 76420-613-90 | 76420061390 | 90 TABLET in 1 BOTTLE (76420-613-90) | 90 tablet | 2023-09-13 | No | No | Current |