Sildenafil
- Product NDC
- 0093-5517
- 11-digit product format
- 000935517
- Labeler code
- 0093
- Product ID
- 0093-5517_7333aab6-b5ad-4345-b8dc-4c89676c7660
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA078380
- Marketing category
- ANDA
- Marketing start
- 2013-05-31
- 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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SILDENAFIL CITRATE | ACTIVE INGREDIENT | BW9B0ZE037 | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| SILDENAFIL | ACTIVE MOIETY | 3M7OB98Y7H | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5517 | SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 19 | Legacy NDC | 20240316_2582414d-0ef3-403e-84e8-1d6c812e7eb1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-5517-98 | 00093551798 | 90 TABLET, FILM COATED in 1 BOTTLE (0093-5517-98) | 2013-05-31 | 0000-00-00 | No | No | Current |