Prescription drug · ANDA
Sildenafil NDC 76282-645
Sildenafil citrate 100 mg/1 · Tablet · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-645-01 | 76282064501 | 100 TABLET in 1 BOTTLE (76282-645-01)Marketed from Jul 1, 2022 | |
| 76282-645-30 | 76282064530 | 30 TABLET in 1 BOTTLE (76282-645-30)Marketed from Jul 1, 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
- Labeler
- Exelan Pharmaceuticals, Inc.
- 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 76282-645_2feb2e90-dc79-4542-87c5-42653c624704SPL ID 2feb2e90-dc79-4542-87c5-42653c624704SPL set ID 1883785c-a1a4-48fe-b722-afacf2875ca8RxCUI 312950, 314228, 314229UNII BW9B0ZE037UPC 0376282644011, 0376282645308, 0376282644301, 0376282643304, 0376282645018
- 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
N476282064501followed by a unit qualifier and the quantityPackage 76282-0645-01. 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 | Appco Pharma LLC | 55801-340 |
| Sildenafil | Sildenafil citrate 100 mg/1 | TabletOral | Proficient Rx LP | 71205-473 |
| Sildenafil | Sildenafil citrate 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-675 |
| 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 |