Sildenafil
- Product NDC
- 59746-471
- 11-digit product format
- 597460471
- Labeler code
- 59746
- Product ID
- 59746-471_9a1dd479-ab39-4e0e-859b-33c7d7dbbf26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA202954
- Marketing category
- ANDA
- Marketing start
- 2024-08-26
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sildenafil
- Listing expiration
- 2027-12-31
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 |
|---|
| 59746-471-05 | Sildenafil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 32 |
| 59746-471-10 | Sildenafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 32 |
| 59746-471-90 | Sildenafil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 32 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59746-471-05 | 59746047105 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-471-05) | 2024-08-26 | No | No | Historical |
| 59746-471-10 | 59746047110 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-471-10) | 2024-08-26 | No | No | Historical |
| 59746-471-90 | 59746047190 | 90 TABLET, FILM COATED in 1 BOTTLE (59746-471-90) | 2024-08-26 | No | No | Historical |