SILDENAFIL
- Product NDC
- 76519-1218
- 11-digit product format
- 765191218
- Labeler code
- 76519
- Product ID
- 76519-1218_7e1d948e-3424-5f9f-e053-2991aa0a6d6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA202659
- Marketing category
- ANDA
- Marketing start
- 2018-12-18
- Marketing end
- 0000-00-00
- Substance
- SILDENAFIL CITRATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 76519-1218-1 | SILDENAFIL | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 76519-1218-3 | SILDENAFIL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1218 | SILDENAFIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 2 package rows | 20190117_7e1d948e-3423-5f9f-e053-2991aa0a6d6d.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 |
|---|
| 76519-1218-1 | 76519121801 | 10 TABLET, FILM COATED in 1 BOTTLE (76519-1218-1) | 2018-12-18 | 0000-00-00 | No | No | Current |
| 76519-1218-3 | 76519121803 | 30 TABLET, FILM COATED in 1 BOTTLE (76519-1218-3) | 2018-12-18 | 0000-00-00 | No | No | Current |