SILDENAFIL
- Product NDC
- 0904-6671
- 11-digit product format
- 009046671
- Labeler code
- 0904
- Product ID
- 0904-6671_93b1a3ca-d3e9-4582-8e17-d2507621675a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6671-04 | SILDENAFIL | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 9 |
| 0904-6671-04 | SILDENAFIL | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 9 |
| 0904-6671-06 | SILDENAFIL | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 9 |
| 0904-6671-06 | SILDENAFIL | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6671 | SILDENAFIL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250410_a65b5fb3-ca3c-4226-9caa-42fb9a2f7373.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6671-04 | 00904667104 | 30 BLISTER PACK in 1 CARTON (0904-6671-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2012-11-06 | 0000-00-00 | No | No | Current |
| 0904-6671-06 | 00904667106 | 50 BLISTER PACK in 1 CARTON (0904-6671-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 2012-11-06 | 0000-00-00 | No | No | Current |