Prescription drug · ANDA
Sildenafil NDC 71335-2657
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2657-0 | 71335265700 | 50 TABLET, FILM COATED in 1 BOTTLE (71335-2657-0)Marketed from Jun 23, 2025 | |
| 71335-2657-1 | 71335265701 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2657-1)Marketed from Jun 23, 2025 | |
| 71335-2657-2 | 71335265702 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2657-2)Marketed from Jun 23, 2025 | |
| 71335-2657-3 | 71335265703 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-2657-3)Marketed from Jun 23, 2025 | |
| 71335-2657-4 | 71335265704 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2657-4)Marketed from Jun 23, 2025 | |
| 71335-2657-5 | 71335265705 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2657-5)Marketed from Jun 23, 2025 | |
| 71335-2657-6 | 71335265706 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2657-6)Marketed from Jun 23, 2025 | |
| 71335-2657-7 | 71335265707 | 270 TABLET, FILM COATED in 1 BOTTLE (71335-2657-7)Marketed from Jun 23, 2025 | |
| 71335-2657-8 | 71335265708 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2657-8)Marketed from Jun 23, 2025 | |
| 71335-2657-9 | 71335265709 | 12 TABLET, FILM COATED in 1 BOTTLE (71335-2657-9)Marketed from Jun 23, 2025 |
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
- Bryant Ranch Prepack
- 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 71335-2657_d6754fca-43f0-4452-aef3-0ad5c126ddfcSPL ID d6754fca-43f0-4452-aef3-0ad5c126ddfcSPL set ID 486dcfc4-f07a-4a78-86f0-f1c5ae448dc1RxCUI 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
N471335265700followed by a unit qualifier and the quantityPackage 71335-2657-00. 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 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 ) 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 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 …
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 Citrate | Sildenafil citrate 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-613 |
| 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 |