Prescription drug · NDA
Revatio (Sildenafil citrate) NDC 58151-385
Sildenafil citrate 10 mg/mL · Powder, For suspension · Oral · Viatris Specialty LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Revatio
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 10 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203109
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 58151-385_51ddbcc2-2d9a-4b24-a02f-d97e2ae060a6SPL ID 51ddbcc2-2d9a-4b24-a02f-d97e2ae060a6SPL set ID 3bb9363e-b28d-4019-8aae-539233dca214RxCUI 577033, 581645, 882527, 882530, 1307427, 1307431UNII 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Adults REVATIO is 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) REVATIO is 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 underlie improvements in exercise [see Clinical Studies (14) ] . Adults REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmo…
Excerpt only. Read the full label for complete information.
About NDC 58151-385
- What is NDC 58151-385?
- 58151-385 is the product NDC for Revatio (sildenafil citrate), Sildenafil citrate 10 mg/mL powder, for suspension, listed with the FDA by Viatris Specialty LLC.
- What drug is associated with this NDC?
- Revatio (Sildenafil citrate).
- What is the active ingredient?
- Sildenafil citrate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Revatio?
- 3 other product NDCs are listed under this name. See all Revatio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Revatio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Revatiosildenafil citrate | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-402 | 58151-0402-77 |
| Revatiosildenafil citrate | Sildenafil citrate .8 mg/mL | Injection, SolutionIntravenous | Viatris Specialty LLC | 58151-395 | 58151-0395-31 |
| Revatiosildenafil citrate | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-4190 | 00069-4190-68 |