Prescription drug · ANDA
Sildenafil NDC 50090-5236
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5236-0 | 50090523600 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5236-0)Marketed from Oct 9, 2020 | |
| 50090-5236-1 | 50090523601 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5236-1)Marketed from Oct 9, 2020 |
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, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203623
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5236_eba51b78-3ceb-4350-9d17-cdd7b188e420SPL ID eba51b78-3ceb-4350-9d17-cdd7b188e420SPL set ID 34845de2-9b11-49c0-b684-cc8efb31386aRxCUI 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
N450090523600followed by a unit qualifier and the quantityPackage 50090-5236-00. 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 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 Patients (1 to 17 Years old) Sildenafil tablets are 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 standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies ( 14 )] . Adults Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203623
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 | NuCare Pharmaceuticals,Inc. | 68071-2213 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-776 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals, Inc. | 72865-105 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1649 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2363 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-619 |