Prescription drug · ANDA
Sildenafil Citrate NDC 70954-408
Sildenafil citrate 50 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-408-10 | 70954040810 | 30 TABLET in 1 BOTTLE (70954-408-10)Marketed from Aug 29, 2023 |
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 Citrate
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216383
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-408_6d8dbaa6-d61a-46ae-a641-f664104f4714SPL ID 6d8dbaa6-d61a-46ae-a641-f664104f4714SPL set ID 6d8dbaa6-d61a-46ae-a641-f664104f4714RxCUI 312950, 314228, 314229UNII BW9B0ZE037UPC 0370954409106, 0370954407102, 0370954408109
- 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
N470954040810followed by a unit qualifier and the quantityPackage 70954-0408-10. 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 is indicated for the treatment of erectile dysfunction. Sildenafil 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 216383
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 Citrate | Sildenafil citrate 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-407 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-409 |