Sildenafil
- Product NDC
- 82347-0215
- 11-digit product format
- 823470215
- Labeler code
- 82347
- Product ID
- 82347-0215_4ff9c8e2-7cb2-aedf-e063-6294a90a0b90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil citrate
- Dosage form
- FILM
- Route
- ORAL
- Labeler
- Yaral Pharma Inc.
- Application
- NDA210858
- Marketing category
- NDA
- Marketing start
- 2026-02-15
- Substance
- SILDENAFIL CITRATE
- Active strength
- 75 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 |
|---|---|
| SILDENAFIL CITRATE | 75 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | BW9B0ZE037 |
| Rxcui | 2735815, 2735822, 2735825, 2735829 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fabccea2-36c8-9268-ee44-ec231455538f | Product name | 9 | 20241217 |
| ac996ae9-22a2-41c2-bb86-913c4aef95ad | Product name | 1 | 20230606 |
| fc95c9f0-00dc-40ef-bcea-b60c9009c5fc | Product name | 9 | 20220613 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82347-0215-4 | Sildenafil | 1 in 1 POUCH | FILM | 1 | 2 | |
| 82347-0215-5 | Sildenafil | 4 in 1 CARTON | FILM | 4 | 2 | |
| 82347-0215-5 | Sildenafil | 1 in 1 POUCH | FILM | 1 | 2 | |
| 82347-0215-6 | Sildenafil | 8 in 1 CARTON | FILM | 8 | 2 | |
| 82347-0215-6 | Sildenafil | 1 in 1 POUCH | FILM | 1 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2735815 | sildenafil 100 MG Oral Film | PSN | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735822 | sildenafil 25 MG Oral Film | PSN | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735825 | sildenafil 50 MG Oral Film | PSN | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735829 | sildenafil 75 MG Oral Film | PSN | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735815 | sildenafil 100 MG Oral Film | SCD | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735822 | sildenafil 25 MG Oral Film | SCD | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735825 | sildenafil 50 MG Oral Film | SCD | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735829 | sildenafil 75 MG Oral Film | SCD | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735815 | sildenafil (as sildenafil citrate) 100 MG Oral Film | SY | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735822 | sildenafil (as sildenafil citrate) 25 MG Oral Film | SY | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735825 | sildenafil (as sildenafil citrate) 50 MG Oral Film | SY | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
| 2735829 | sildenafil (as sildenafil citrate) 75 MG Oral Film | SY | a17a970e-25a2-4807-9644-74e6d2bd2383 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82347-0215-4 | 82347021504 | 1 FILM in 1 POUCH (82347-0215-4) | 1 film | 2026-02-15 | No | No | Current |
| 82347-0215-5 | 82347021505 | 4 POUCH in 1 CARTON (82347-0215-5) / 1 FILM in 1 POUCH | 4 pouch | 2026-02-15 | No | No | Current |
| 82347-0215-6 | 82347021506 | 8 POUCH in 1 CARTON (82347-0215-6) / 1 FILM in 1 POUCH | 8 pouch | 2026-02-15 | No | No | Current |