Sildenafil
- Product NDC
- 0378-1659
- 11-digit product format
- 003781659
- Labeler code
- 0378
- Product ID
- 0378-1659_1d0e6262-2e9e-43ca-8f44-5f7e202a662c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA201171
- Marketing category
- ANDA
- Marketing start
- 2019-04-04
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1659 | SILDENAFIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20250215_cad6e3ac-84e5-4dae-9c26-8f6078f0da0c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1659-93 | 00378165993 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1659-93) | 2019-04-04 | 0000-00-00 | No | No | Current |