Prescription drug · ANDA
Sildenafil Citrate NDC 80425-0503
Sildenafil citrate 100 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0503-1 | 80425050301 | 30 TABLET in 1 BOTTLE (80425-0503-1)Marketed from Mar 20, 2025 | |
| 80425-0503-2 | 80425050302 | 60 TABLET in 1 BOTTLE (80425-0503-2)Marketed from Mar 20, 2025 | |
| 80425-0503-3 | 80425050303 | 90 TABLET in 1 BOTTLE (80425-0503-3)Marketed from Mar 20, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sildenafil Citrate
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209302
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0503_30cb703a-6916-b436-e063-6294a90a5608SPL ID 30cb703a-6916-b436-e063-6294a90a5608SPL set ID 30cb7d6a-ce40-c794-e063-6294a90a6861RxCUI 314229UNII BW9B0ZE037
- Pharmacologic class
- Phosphodiesterase 5 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425050301followed by a unit qualifier and the quantityPackage 80425-0503-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209302
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-079 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-240 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-241 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8804 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Proficient Rx LP | 71205-657 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7181 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | Proficient Rx LP | 71205-721 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-404 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-405 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-406 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-272 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | TabletOral | Proficient Rx LP | 82804-251 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | Proficient Rx LP | 71205-795 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-003 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-002 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | Northstar Rx LLC | 72603-884 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | TabletOral | Northstar Rx LLC | 72603-883 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Northstar Rx LLC | 72603-885 |