Prescription drug · ANDA
Sildenafil NDC 68071-3978
Sildenafil citrate 50 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3978-9 | 68071397809 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3978-9)Marketed from Mar 26, 2026 |
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
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202255
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3978_4df499a6-8fe4-b392-e063-6394a90ae50dSPL ID 4df499a6-8fe4-b392-e063-6394a90ae50dSPL set ID 4df47282-7950-9430-e063-6394a90af579RxCUI 312950UNII 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
N468071397809followed by a unit qualifier and the quantityPackage 68071-3978-09. 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)
Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets are 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 ANDA 202255
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 50 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-042 |
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-041 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-043 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7977 |