Sildenafil Citrate
- Product NDC
- 82009-093
- 11-digit product format
- 820090093
- Labeler code
- 82009
- Product ID
- 82009-093_853230e4-4f33-420e-bd3c-d5b45f4e0689
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA206401
- Marketing category
- ANDA
- Marketing start
- 2023-07-19
- 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 Citrate
- 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 | 314229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-093-01 | Sildenafil Citrate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-093 | SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 1 | Current NDC, 1 package rows | 20230721_41b67fd2-3d9a-49d6-88b8-285044b98dc1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-093-01 | 82009009301 | 100 TABLET, FILM COATED in 1 BOTTLE (82009-093-01) | 2023-07-19 | No | No | Current |