Sildenafil
- Product NDC
- 0093-5342
- 11-digit product format
- 000935342
- Labeler code
- 0093
- Product ID
- 0093-5342_f85e5bfc-be48-4675-8867-1585f412ccb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077342
- Marketing category
- ANDA
- Marketing start
- 2017-12-11
- Substance
- SILDENAFIL CITRATE
- Active strength
- 50 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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| ac996ae9-22a2-41c2-bb86-913c4aef95ad | Product name | 1 | 20230606 |
| fc95c9f0-00dc-40ef-bcea-b60c9009c5fc | Product name | 9 | 20220613 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-5342-01 | Sildenafil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 8 | |
| 0093-5342-56 | Sildenafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-5342-01 | EA - Each | 0093-5342 | 1c7fbe0c-be58-43a6-b319-0467c3bd040d | 1 | 2018-01-12 |
| 0093-5342-56 | EA - Each | 0093-5342 | 580460cb-8ab7-49f4-8928-2861785b2157 | 1 | 2018-01-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 314228 | sildenafil citrate 25 MG Oral Tablet | PSN | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 314228 | sildenafil 25 MG Oral Tablet | SCD | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 314228 | sildenafil 25 MG (as sildenafil citrate) Oral Tablet | SY | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | 5cbac450-f336-45bd-8d10-9ecfd21866eb | 8 |
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | 94eb1f59-2a7d-4230-9ae6-69c34d083326 | 3 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | 94eb1f59-2a7d-4230-9ae6-69c34d083326 | 3 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | 94eb1f59-2a7d-4230-9ae6-69c34d083326 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0093-5342-01 | 00093534201 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5342-01) | 2017-12-11 | 0000-00-00 | No | No | Current |
| 0093-5342-56 | 00093534256 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5342-56) | 2017-12-11 | 0000-00-00 | No | No | Current |