Sildenafil
- Product NDC
- 50436-1210
- 11-digit product format
- 504361210
- Labeler code
- 50436
- Product ID
- 50436-1210_00ae7c9e-960a-407a-a705-e5b708a7d026
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA203814
- Marketing category
- ANDA
- Marketing start
- 2014-01-03
- Marketing end
- 0000-00-00
- Substance
- SILDENAFIL CITRATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50436-1210-1 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-2 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-3 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-4 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-5 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-6 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-1 | 2022-03-01 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-2 | 2022-03-01 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-3 | 2022-03-01 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-4 | 2022-03-01 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-5 | 2022-03-01 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-6 | 2022-03-01 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
| 50436-1210-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1964-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-1210-1 | Sildenafil | 3 in 1 POUCH | TABLET, FILM COATED | 3 | | 8 |
| 50436-1210-1 | Sildenafil | 250 in 1 CASE | TABLET, FILM COATED | 250 | | 8 |
| 50436-1210-2 | Sildenafil | 3 in 1 POUCH | TABLET, FILM COATED | 3 | | 8 |
| 50436-1210-2 | Sildenafil | 200 in 1 CASE | TABLET, FILM COATED | 200 | | 8 |
| 50436-1210-3 | Sildenafil | 4 in 1 POUCH | TABLET, FILM COATED | 4 | | 8 |
| 50436-1210-3 | Sildenafil | 200 in 1 CASE | TABLET, FILM COATED | 200 | | 8 |
| 50436-1210-4 | Sildenafil | 5 in 1 POUCH | TABLET, FILM COATED | 5 | | 8 |
| 50436-1210-4 | Sildenafil | 200 in 1 CASE | TABLET, FILM COATED | 200 | | 8 |
| 50436-1210-5 | Sildenafil | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 8 |
| 50436-1210-5 | Sildenafil | 200 in 1 CASE | TABLET, FILM COATED | 200 | | 8 |
| 50436-1210-6 | Sildenafil | 2 in 1 POUCH | TABLET, FILM COATED | 2 | | 8 |
| 50436-1210-6 | Sildenafil | 200 in 1 CASE | TABLET, FILM COATED | 200 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-1210 | SILDENAFIL TABLET, FILM COATED [UNIT DOSE SERVICES] | 8 | Legacy NDC, 12 package rows | 20220302_b812890c-41a1-4f72-a06a-b550a0ca034e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50436-1210-1 | 50436121001 | 250 POUCH in 1 CASE (50436-1210-1) > 3 TABLET, FILM COATED in 1 POUCH | 250 pouch | 2018-04-04 | 0000-00-00 | No | No | Current |
| 50436-1210-2 | 50436121002 | 200 POUCH in 1 CASE (50436-1210-2) > 3 TABLET, FILM COATED in 1 POUCH | 200 pouch | 2018-08-01 | 0000-00-00 | No | No | Current |
| 50436-1210-3 | 50436121003 | 200 POUCH in 1 CASE (50436-1210-3) > 4 TABLET, FILM COATED in 1 POUCH | 200 pouch | 2018-08-01 | 0000-00-00 | No | No | Current |
| 50436-1210-4 | 50436121004 | 200 POUCH in 1 CASE (50436-1210-4) > 5 TABLET, FILM COATED in 1 POUCH | 200 pouch | 2018-08-01 | 0000-00-00 | No | No | Current |
| 50436-1210-5 | 50436121005 | 200 POUCH in 1 CASE (50436-1210-5) > 1 TABLET, FILM COATED in 1 POUCH | 200 pouch | 2018-11-13 | 0000-00-00 | No | No | Current |
| 50436-1210-6 | 50436121006 | 200 POUCH in 1 CASE (50436-1210-6) > 2 TABLET, FILM COATED in 1 POUCH | 200 pouch | 2018-11-13 | 0000-00-00 | No | No | Current |