Sildenafil
- Product NDC
- 70954-168
- 11-digit product format
- 709540168
- Labeler code
- 70954
- Product ID
- 70954-168_7e36fae8-7fbe-44fe-a951-66f18f1b3fe1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil citrate
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA212260
- Marketing category
- ANDA
- Marketing start
- 2019-05-31
- Substance
- SILDENAFIL CITRATE
- Active strength
- 10 mg/mL
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILDENAFIL CITRATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BW9B0ZE037 |
| Rxcui | 1307427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-168-10 | Sildenafil | 112 mL in 1 BOTTLE | FOR SUSPENSION | 112 | | 4 |
| 70954-168-10 | Sildenafil | 1 in 1 CARTON | FOR SUSPENSION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-168 | SILDENAFIL (SILDENAFIL CITRATE) FOR SUSPENSION [ANI PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240203_083da718-e934-4941-b083-a19b4ebe3935.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70954-168-10 | 70954016810 | 1 BOTTLE in 1 CARTON (70954-168-10) / 112 mL in 1 BOTTLE | 1 bottle | 2019-05-31 | 0000-00-00 | No | No | Current |