SILDENAFIL
- Product NDC
- 76282-645
- 11-digit product format
- 762820645
- Labeler code
- 76282
- Product ID
- 76282-645_2feb2e90-dc79-4542-87c5-42653c624704
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA207178
- Marketing category
- ANDA
- Marketing start
- 2022-07-01
- 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 |
|---|---|---|---|---|---|---|
| 76282-645-01 | SILDENAFIL | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 76282-645-30 | SILDENAFIL | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76282-645-01 | EA - Each | 76282-645 | badb80a9-5e84-47b8-aa9b-bc4bcd95e9fb | 1 | 2023-01-09 |
| 76282-645-30 | EA - Each | 76282-645 | ef12f0f3-c368-4a9f-91d8-d089d1377b6b | 1 | 2023-01-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 4 |
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 4 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 4 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 4 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 4 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 4 |
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 314228 | sildenafil citrate 25 MG Oral Tablet | PSN | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 314228 | sildenafil 25 MG Oral Tablet | SCD | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 314228 | sildenafil 25 MG (as sildenafil citrate) Oral Tablet | SY | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76282-645-01 | 76282064501 | 100 TABLET in 1 BOTTLE (76282-645-01) | 100 tablet | 2022-07-01 | 0000-00-00 | No | No | Current |
| 76282-645-30 | 76282064530 | 30 TABLET in 1 BOTTLE (76282-645-30) | 30 tablet | 2022-07-01 | 0000-00-00 | No | No | Current |