Prescription drug · ANDA
Sildenafil NDC 63187-619
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-619-10 | 63187061910 | 10 TABLET, FILM COATED in 1 BOTTLE (63187-619-10)Marketed from Dec 1, 2018 | |
| 63187-619-30 | 63187061930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-619-30)Marketed from Dec 1, 2018 | |
| 63187-619-60 | 63187061960 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-619-60)Marketed from Dec 1, 2018 | |
| 63187-619-90 | 63187061990 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-619-90)Marketed from Dec 1, 2018 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-619_71f30593-dbe4-4344-a576-6b6432ce3c64SPL ID 71f30593-dbe4-4344-a576-6b6432ce3c64SPL set ID 55a53f64-c04a-4697-9db3-d0827fdfcc2bRxCUI 577033UNII BW9B0ZE037UPC 0363187619206
- 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
N463187061910followed by a unit qualifier and the quantityPackage 63187-0619-10. 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 pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14) ] . Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial h…
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 | A-S Medication Solutions | 50090-5236 |