Prescription drug · ANDA
Sildenafil NDC 50268-717
Sildenafil citrate 20 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-717-15 | 50268071715 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-717-15) / 1 TABLET in 1 BLISTER PACK (50268-717-11)Marketed from May 29, 2015 |
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
- AvPAK
- 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 50268-717_436cc2bc-6fb4-227a-e063-6294a90ae221SPL ID 436cc2bc-6fb4-227a-e063-6294a90ae221SPL set ID e08de794-9b7e-aae6-9c89-a0c0d090cc76RxCUI 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
N450268071715followed by a unit qualifier and the quantityPackage 50268-0717-15. 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 pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14) ]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hyper…
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 | REMEDYREPACK INC. | 70518-4596 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-351 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-351 |