Prescription drug · NDA AUTHORIZED GENERIC
Sildenafil Citrate NDC 59762-0035
Sildenafil citrate 50 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0035-1 | 59762003501 | 30 TABLET, FILM COATED in 1 BOTTLE (59762-0035-1)Marketed from Dec 1, 2017 | |
| 59762-0035-2 | 59762003502 | 100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2)Marketed from Dec 1, 2017 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020895
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 59762-0035_6b8ead94-5df8-4fbd-a75e-388f8147fe5dSPL ID 6b8ead94-5df8-4fbd-a75e-388f8147fe5dSPL set ID 98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0RxCUI 312950, 314228, 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
N459762003501followed by a unit qualifier and the quantityPackage 59762-0035-01. 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 citrate tablets are indicated for the treatment of erectile dysfunction. Sildenafil citrate tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020895
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 |
|---|---|---|---|---|
| Viagrasildenafil citrate | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-4210 |
| Viagrasildenafil citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-4200 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0034 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0036 |
| Viagrasildenafil citrate | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-4220 |
| Viagrasildenafil citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-426 |
| Viagrasildenafil citrate | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-427 |
| Viagrasildenafil citrate | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-428 |