Sildenafil
- Product NDC
- 65862-690
- 11-digit product format
- 658620690
- Labeler code
- 65862
- Product ID
- 65862-690_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203962
- Marketing category
- ANDA
- Marketing start
- 2018-06-11
- Substance
- SILDENAFIL CITRATE
- Active strength
- 50 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 | 50 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 |
|---|
| 65862-690-01 | Sildenafil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 65862-690-05 | Sildenafil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 65862-690-30 | Sildenafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 65862-690-99 | Sildenafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-690 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240618_363c1e77-e482-47b2-aa1e-851abd770aeb.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 |
|---|
| 65862-690-01 | 65862069001 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-690-01) | 2018-06-11 | 0000-00-00 | No | No | Current |
| 65862-690-05 | 65862069005 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-690-05) | 2023-07-10 | | No | No | Historical |
| 65862-690-30 | 65862069030 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-690-30) | 2018-06-11 | 0000-00-00 | No | No | Current |
| 65862-690-99 | 65862069099 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-690-99) | 2018-06-11 | 0000-00-00 | No | No | Current |