Sildenafil
- Product NDC
- 65862-688
- 11-digit product format
- 658620688
- Labeler code
- 65862
- Product ID
- 65862-688_aee36818-4865-49b7-9f54-29c62f8d4fda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203963
- Marketing category
- ANDA
- Marketing start
- 2015-11-18
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sildenafil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILDENAFIL CITRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BW9B0ZE037 |
| Rxcui | 577033 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-688-90 | Sildenafil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
| 65862-688-99 | Sildenafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SILDENAFIL CITRATE | ACTIVE INGREDIENT | BW9B0ZE037 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| SILDENAFIL | ACTIVE MOIETY | 3M7OB98Y7H | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-688 | SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250216_17621e92-79a0-46aa-86c7-ea179e81928d.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 |
|---|
| 65862-688-90 | 65862068890 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-688-90) | 2015-11-18 | 0000-00-00 | No | No | Current |
| 65862-688-99 | 65862068899 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-688-99) | 2015-11-18 | 0000-00-00 | No | No | Current |