Prescription drug · ANDA
Sildenafil NDC 71610-675
Sildenafil citrate 100 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-675-02 | 71610067502 | 2 TABLET in 1 BOTTLE (71610-675-02)Marketed from Nov 7, 2022 | |
| 71610-675-03 | 71610067503 | 9 TABLET in 1 BOTTLE (71610-675-03)Marketed from Nov 7, 2022 | |
| 71610-675-04 | 71610067504 | 4 TABLET in 1 BOTTLE (71610-675-04)Marketed from Nov 7, 2022 | |
| 71610-675-06 | 71610067506 | 6 TABLET in 1 BOTTLE (71610-675-06)Marketed from Nov 7, 2022 | |
| 71610-675-12 | 71610067512 | 12 TABLET in 1 BOTTLE (71610-675-12)Marketed from Nov 7, 2022 | |
| 71610-675-33 | 71610067533 | 3 TABLET in 1 BOTTLE (71610-675-33)Marketed from Dec 1, 2022 | |
| 71610-675-52 | 71610067552 | 18 TABLET in 1 BOTTLE (71610-675-52)Marketed from Nov 7, 2022 |
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
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207178
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-675_f4dbdb1b-c31d-4418-abd9-883eef04d5bdSPL ID f4dbdb1b-c31d-4418-abd9-883eef04d5bdSPL set ID cdab7ef5-39cb-45cc-b2bf-5f634f2f5499RxCUI 312950, 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
N471610067502followed by a unit qualifier and the quantityPackage 71610-0675-02. 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 is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207178
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 25 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-643 |
| Sildenafil | Sildenafil citrate 25 mg/1 | TabletOral | Appco Pharma LLC | 55801-338 |
| Sildenafil | Sildenafil citrate 50 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-644 |
| Sildenafil | Sildenafil citrate 50 mg/1 | TabletOral | Appco Pharma LLC | 55801-339 |
| Sildenafil | Sildenafil citrate 100 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-645 |
| Sildenafil | Sildenafil citrate 100 mg/1 | TabletOral | Appco Pharma LLC | 55801-340 |
| Sildenafil | Sildenafil citrate 100 mg/1 | TabletOral | Proficient Rx LP | 71205-473 |
| Sildenafil | Sildenafil citrate 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-679 |
| Sildenafil | Sildenafil citrate 50 mg/1 | TabletOral | CIPLA USA INC., | 69097-952 |
| Sildenafil | Sildenafil citrate 25 mg/1 | TabletOral | CIPLA USA INC., | 69097-951 |
| Sildenafil | Sildenafil citrate 100 mg/1 | TabletOral | CIPLA USA INC., | 69097-953 |