Prescription drug · ANDA
Sildenafil Citrate (sildenafil) NDC 71205-305
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-305-10 | 71205030510 | 10 TABLET, FILM COATED in 1 BOTTLE (71205-305-10)Marketed from Aug 1, 2019 | |
| 71205-305-20 | 71205030520 | 20 TABLET, FILM COATED in 1 BOTTLE (71205-305-20)Marketed from Aug 1, 2019 | |
| 71205-305-30 | 71205030530 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-305-30)Marketed from Aug 1, 2019 | |
| 71205-305-60 | 71205030560 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-305-60)Marketed from Aug 1, 2019 | |
| 71205-305-90 | 71205030590 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-305-90)Marketed from Aug 1, 2019 |
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
- 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 204883
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-305_4f09b702-450f-4270-8e1a-2402677095cdSPL ID 4f09b702-450f-4270-8e1a-2402677095cdSPL set ID 9ebc1a11-3f4b-4eb3-89f5-f430a330887dRxCUI 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
N471205030510followed by a unit qualifier and the quantityPackage 71205-0305-10. 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)
1. INDICATIONS AND USAGE Sildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). ( 1 ) Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1 , 14 ) Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204883
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 Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-623 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-018 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | TruPharma LLC | 52817-295 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-094 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-793 |