Prescription drug · ANDA
Sildenafil NDC 82804-243
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-243-30 | 8280402433082804024330 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-243-30)Marketed from Sep 10, 2025 | |
| 82804-243-90 | 8280402439082804024390 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-243-90)Marketed from Sep 15, 2025 |
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 LPNDC labeler code 82804
- 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 82804-243_71140bd5-0a51-4c01-ad0d-193d08ea67ddSPL ID 71140bd5-0a51-4c01-ad0d-193d08ea67ddSPL set ID 71140bd5-0a51-4c01-ad0d-193d08ea67ddRxCUI 577033UNII BW9B0ZE037UPC 0382804243303
- 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
N482804024330followed by a unit qualifier and the quantityPackage 82804-0243-30. 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 ) 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.
About NDC 82804-243
- What is NDC 82804-243?
- 82804-243 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sildenafil.
- What is the active ingredient?
- Sildenafil citrate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sildenafil?
- 150 other product NDCs are listed under this name. See all Sildenafil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sildenafil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-434 | 59746-0434-0359746-0434-0459746-0434-05+2 more |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-435 | 59746-0435-0159746-0435-0359746-0435-04+3 more |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-436 | 59746-0436-0159746-0436-0359746-0436-04+3 more |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4596 | 70518-4596-00 |
| Sildenafilsildenafil citrate | Sildenafil citrate 25 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0205 | 82347-0205-0482347-0205-0582347-0205-06 |
| Sildenafilsildenafil citrate | Sildenafil citrate 50 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0210 | 82347-0210-0482347-0210-0582347-0210-06 |
| Sildenafilsildenafil citrate | Sildenafil citrate 75 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0215 | 82347-0215-0482347-0215-0582347-0215-06 |
| Sildenafilsildenafil citrate | Sildenafil citrate 100 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0220 | 82347-0220-0482347-0220-0582347-0220-06 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-987 | 51407-0987-90 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | AvKARE | 42291-937 | 42291-0937-90 |
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 | Major Pharmaceuticals | 0904-6671 |
| 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 | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2657 |
| Sildenafil Citrate | Sildenafil citrate 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-3905 |
| Sildenafil Citrate | Sildenafil citrate 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-613 |
| Sildenafil Citrate | Sildenafil citrate 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0304 |