Sildenafil
- Product NDC
- 60219-1753
- 11-digit product format
- 602191753
- Labeler code
- 60219
- Product ID
- 60219-1753_8148bd41-7822-4d86-b60e-d6b01060d3a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA202023
- Marketing category
- ANDA
- Marketing start
- 2018-06-28
- 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
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 |
|---|---|---|---|---|---|---|
| 60219-1753-1 | Sildenafil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 12 | |
| 60219-1753-3 | Sildenafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 12 | |
| 60219-1753-7 | Sildenafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60219-1753-3 | EA - Each | 60219-1753 | 7a949024-1edd-451b-85cf-2f18ae1c672c | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60219-1753 | SILDENAFIL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20231128_a1c3a2a2-8cf5-41c3-9c86-54290570d916.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 314228 | sildenafil citrate 25 MG Oral Tablet | PSN | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 314228 | sildenafil 25 MG Oral Tablet | SCD | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 314228 | sildenafil 25 MG (as sildenafil citrate) Oral Tablet | SY | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 12 |
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | 96ae6733-cef9-46cf-bf4e-5368201943bd | 7 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | 96ae6733-cef9-46cf-bf4e-5368201943bd | 7 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | 96ae6733-cef9-46cf-bf4e-5368201943bd | 7 |
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | f98d51a5-e3c8-2b6c-e053-6294a90ac146 | 2 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | f98d51a5-e3c8-2b6c-e053-6294a90ac146 | 2 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | f98d51a5-e3c8-2b6c-e053-6294a90ac146 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60219-1753-1 | 60219175301 | 100 TABLET, FILM COATED in 1 BOTTLE (60219-1753-1) | 2018-06-28 | 0000-00-00 | No | No | Current |
| 60219-1753-3 | 60219175303 | 30 TABLET, FILM COATED in 1 BOTTLE (60219-1753-3) | 2018-06-28 | 0000-00-00 | No | No | Current |
| 60219-1753-7 | 60219175307 | 1000 TABLET, FILM COATED in 1 BOTTLE (60219-1753-7) | 2018-06-28 | No | No | Historical |