Prescription drug · ANDA
Sildenafil NDC 70518-3433
Sildenafil citrate 20 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3433-2 | 70518343302 | 360 POUCH in 1 BOX (70518-3433-2) / 1 TABLET in 1 POUCH (70518-3433-1)Marketed from Jun 9, 2022 | |
| 70518-3433-4 | 70518343304 | 180 POUCH in 1 BOX (70518-3433-4) / 1 TABLET in 1 POUCH (70518-3433-1)Marketed from Jan 10, 2024 | |
| 70518-3433-5 | 70518343305 | 100 POUCH in 1 BOX (70518-3433-5) / 1 TABLET in 1 POUCH (70518-3433-1)Marketed from Jul 8, 2026 | |
| 70518-3433-6 | 70518343306 | 50 POUCH in 1 BOX (70518-3433-6) / 1 TABLET in 1 POUCH (70518-3433-1)Marketed from Jul 8, 2026 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210394
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-3433_562d2978-ebba-15dd-e063-6294a90a0503SPL ID 562d2978-ebba-15dd-e063-6294a90a0503SPL set ID e4f41e9e-d508-4f91-8677-8a19b07139deRxCUI 577033UNII 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
N470518343302followed by a unit qualifier and the quantityPackage 70518-3433-02. 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)
Adults Sildenafil tablets, USP are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ( 14 )]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210394
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 20 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-094 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-124 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Proficient Rx LP | 82804-185 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1963 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | DirectRx | 72189-298 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2537 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2602 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7974 |