Sildenafil
- Product NDC
- 33342-043
- 11-digit product format
- 333420043
- Labeler code
- 33342
- Product ID
- 33342-043_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202255
- Marketing category
- ANDA
- Marketing start
- 2023-04-19
- Substance
- SILDENAFIL CITRATE
- Active strength
- 100 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 | 100 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 |
|---|
| 33342-043-07 | Sildenafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 33342-043-11 | Sildenafil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 33342-043-44 | Sildenafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
| 33342-043-98 | Sildenafil | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 33342-043-98 | Sildenafil | 60 in 1 BLISTER PACK | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-043 | SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 5 package rows | 20230505_c2b25818-99a3-474b-a04c-929df1110834.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 |
|---|
| 33342-043-07 | 33342004307 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07) | | 2023-04-19 | No | No | Current |
| 33342-043-11 | 33342004311 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-043-11) | | 2023-04-19 | No | No | Current |
| 33342-043-44 | 33342004344 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-043-44) | | 2023-04-19 | No | No | Current |
| 33342-043-98 | 33342004398 | 1 BLISTER PACK in 1 CARTON (33342-043-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-04-19 | No | No | Current |