Prescription drug · ANDA
Sildenafil Citrate NDC 76420-613
Sildenafil citrate 20 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-613-30 | 76420061330 | 30 TABLET in 1 BOTTLE (76420-613-30)Marketed from Sep 13, 2023 | |
| 76420-613-60 | 76420061360 | 60 TABLET in 1 BOTTLE (76420-613-60)Marketed from Sep 13, 2023 | |
| 76420-613-90 | 76420061390 | 90 TABLET in 1 BOTTLE (76420-613-90)Marketed from Sep 13, 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091479
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-613_05373fec-0f63-7fd4-e063-6394a90af72dSPL ID 05373fec-0f63-7fd4-e063-6394a90af72dSPL set ID 49a95b25-08b3-4cfe-a60b-c5132c280be2RxCUI 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
N476420061330followed by a unit qualifier and the quantityPackage 76420-0613-30. 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 citrate is 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 clinical worsening. ( 1 ) Pediatric Patients (1 to17 years old) Sildenafil tablet is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise ( 1 , 14 ) Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hyp…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091479
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 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2657 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-185 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4307 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3954 |
| Sildenafil Citrate | Sildenafil citrate 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0304 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-243 |
| Sildenafil Citrate | Sildenafil citrate 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-3905 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6671 |