Prescription drug · ANDA
Sildenafil NDC 68071-2985
Sildenafil citrate 100 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2985-3 | 68071298503 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2985-3)Marketed from Apr 17, 2023 |
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 — 100 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 202023
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2985_2dcdd45a-556b-0b9f-e063-6394a90a8a3fSPL ID 2dcdd45a-556b-0b9f-e063-6394a90a8a3fSPL set ID f98d51a5-e3c8-2b6c-e053-6294a90ac146RxCUI 314229UNII BW9B0ZE037UPC 0368071298536
- 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
N468071298503followed by a unit qualifier and the quantityPackage 68071-2985-03. 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 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 ANDA 202023
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 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0969 |
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1751 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1752 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1753 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7833 |