Sildenafil Citrate
- Product NDC
- 68071-3549
- 11-digit product format
- 680713549
- Labeler code
- 68071
- Product ID
- 68071-3549_1884bfe6-392b-09dd-e063-6394a90aad46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA206401
- Marketing category
- ANDA
- Marketing start
- 2018-10-12
- Substance
- SILDENAFIL CITRATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sildenafil Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILDENAFIL CITRATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BW9B0ZE037 |
| Rxcui | 314229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3549-1 | Sildenafil Citrate | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 4 |
| 68071-3549-5 | Sildenafil Citrate | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 4 |
| 68071-3549-6 | Sildenafil Citrate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68071-3549-9 | Sildenafil Citrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3549 | SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, 4 package rows | 20240517_0bb3eb8d-05cd-b4cd-e063-6294a90a94bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3549-1 | 68071354901 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-3549-1) | 2024-05-15 | No | No | Current |
| 68071-3549-5 | 68071354905 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3549-5) | 2023-12-04 | No | No | Current |
| 68071-3549-6 | 68071354906 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3549-6) | 2023-12-04 | No | No | Current |
| 68071-3549-9 | 68071354909 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3549-9) | 2024-04-09 | No | No | Current |