Prescription drug · ANDA
Sildenafil NDC 65162-351
Sildenafil citrate 20 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-351-09 | 65162035109 | 90 TABLET in 1 BOTTLE (65162-351-09)Marketed from Nov 8, 2012 | |
| 65162-351-11 | 65162035111 | 1000 TABLET in 1 BOTTLE (65162-351-11)Marketed from Nov 8, 2012 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202025
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-351_de64b88f-aefc-40f1-8db7-d65dba8194aaSPL ID de64b88f-aefc-40f1-8db7-d65dba8194aaSPL set ID 187de471-3e79-44ed-b560-0f8b2d549f74RxCUI 577033UNII 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
N465162035109followed by a unit qualifier and the quantityPackage 65162-0351-09. 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)
Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14) ] . Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202025
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 | Sildenafil citrate 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-1766 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | AvKARE | 42291-937 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-172 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5029 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Proficient Rx LP | 63187-789 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | AvPAK | 50268-717 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4596 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-351 |