Prescription drug · ANDA
Sildenafil Citrate (sildenafil) NDC 68071-3631
Sildenafil citrate 50 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3631-3 | 68071363103 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3631-3)Marketed from Jun 17, 2024 |
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
- 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 206401
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3631_58c77fae-41db-2279-e063-6294a90afe6eSPL ID 58c77fae-41db-2279-e063-6294a90afe6eSPL set ID 1b1ab00d-de9c-4614-e063-6394a90afcdeRxCUI 312950UNII BW9B0ZE037UPC 0368071363135
- 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
N468071363103followed by a unit qualifier and the quantityPackage 68071-3631-03. 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 citrate is indicated for the treatment of erectile dysfunction. Sildenafil citrate is 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 206401
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 Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-093 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3592 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5906 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1437 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3646 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3670 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3410 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8301 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-025 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3549 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-564 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-563 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-565 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Ajanta Pharma USA Inc. | 27241-069 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Ajanta Pharma USA Inc. | 27241-067 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0410 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Ajanta Pharma USA Inc. | 27241-068 |