Sildenafil
- Product NDC
- 50436-0033
- 11-digit product format
- 504360033
- Labeler code
- 50436
- Product ID
- 50436-0033_3017ecea-bcb6-4c5a-a066-5944b4ef24e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil citrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- NDA021845
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-09-27
- 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
- 2022-12-31
- 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 |
|---|
| 50436-0033-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-1 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-2 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-3 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-4 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-5 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 |
| 50436-0033-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4875-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. 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 |
|---|
| 50436-0033-1 | Sildenafil | 1890 in 1 CASE | TABLET, FILM COATED | 1890 | | 3 |
| 50436-0033-1 | Sildenafil | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 3 |
| 50436-0033-2 | Sildenafil | 1620 in 1 CASE | TABLET, FILM COATED | 1620 | | 3 |
| 50436-0033-2 | Sildenafil | 2 in 1 POUCH | TABLET, FILM COATED | 2 | | 3 |
| 50436-0033-3 | Sildenafil | 1620 in 1 CASE | TABLET, FILM COATED | 1620 | | 3 |
| 50436-0033-3 | Sildenafil | 3 in 1 POUCH | TABLET, FILM COATED | 3 | | 3 |
| 50436-0033-4 | Sildenafil | 4 in 1 POUCH | TABLET, FILM COATED | 4 | | 3 |
| 50436-0033-4 | Sildenafil | 1350 in 1 CASE | TABLET, FILM COATED | 1350 | | 3 |
| 50436-0033-5 | Sildenafil | 1350 in 1 CASE | TABLET, FILM COATED | 1350 | | 3 |
| 50436-0033-5 | Sildenafil | 5 in 1 POUCH | TABLET, FILM COATED | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-0033 | SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [UNIT DOSE SERVICES] | 3 | Legacy NDC, 10 package rows | 20210217_f2abd969-5ff1-413b-80ab-5e3939116877.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 |
|---|
| 50436-0033-1 | 50436003301 | 1890 POUCH in 1 CASE (50436-0033-1) > 1 TABLET, FILM COATED in 1 POUCH | 1890 pouch | 2021-02-16 | 0000-00-00 | No | No | Current |
| 50436-0033-2 | 50436003302 | 1620 POUCH in 1 CASE (50436-0033-2) > 2 TABLET, FILM COATED in 1 POUCH | 1620 pouch | 2021-02-16 | 0000-00-00 | No | No | Current |
| 50436-0033-3 | 50436003303 | 1620 POUCH in 1 CASE (50436-0033-3) > 3 TABLET, FILM COATED in 1 POUCH | 1620 pouch | 2021-02-16 | 0000-00-00 | No | No | Current |
| 50436-0033-4 | 50436003304 | 1350 POUCH in 1 CASE (50436-0033-4) > 4 TABLET, FILM COATED in 1 POUCH | 1350 pouch | 2021-02-16 | 0000-00-00 | No | No | Current |
| 50436-0033-5 | 50436003305 | 1350 POUCH in 1 CASE (50436-0033-5) > 5 TABLET, FILM COATED in 1 POUCH | 1350 pouch | 2021-02-16 | 0000-00-00 | No | No | Current |