Sildenafil
- Product NDC
- 76519-1135
- 11-digit product format
- 765191135
- Labeler code
- 76519
- Product ID
- 76519-1135_5dfacc4f-116e-805b-e053-2991aa0a30a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H. J. Harkins Company Inc.
- Application
- ANDA203814
- Marketing category
- ANDA
- Marketing start
- 2017-11-02
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76519-1135-3 | Sildenafil | 30 in 1 CONTAINER | TABLET, FILM COATED | 30 | | 1 |
| 76519-1135-9 | Sildenafil | 90 in 1 CONTAINER | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1135 | SILDENAFIL TABLET, FILM COATED [H. J. HARKINS COMPANY INC.] | 1 | Legacy NDC, 2 package rows | 20171128_5dfacc4f-116d-805b-e053-2991aa0a30a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1135-3 | 76519113503 | 30 in 1 CONTAINER | Historical |
| 76519-1135-9 | 76519113509 | 90 in 1 CONTAINER | Historical |