Prescription drug · NDA
Revatio (Sildenafil citrate) NDC 0069-4190
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · PFIZER LABORATORIES DIV PFIZER INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-4190-68 | 0006941906800069419068 | 90 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68)Marketed from Jun 3, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Revatio
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PFIZER LABORATORIES DIV PFIZER INCNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021845
- Marketing start
- Marketing end
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 0069-4190_9fcb9918-6486-4715-8733-d5ff24a2679dSPL ID 9fcb9918-6486-4715-8733-d5ff24a2679dSPL set ID f158fe10-d5dc-4432-b2c9-fc665401291bRxCUI 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.
- NDC on a medical claim
N400069419068followed by a unit qualifier and the quantityPackage 00069-4190-68. 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 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 0069-4190
- What is NDC 0069-4190?
- 0069-4190 is the product NDC for Revatio (sildenafil citrate), Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by PFIZER LABORATORIES DIV PFIZER INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Revatio (Sildenafil citrate).
- What is the active ingredient?
- Sildenafil citrate.
- Who is the labeler?
- PFIZER LABORATORIES DIV PFIZER INC, NDC labeler code 0069. 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 10 mg/mL | Powder, For suspensionOral | Viatris Specialty LLC | 58151-385 | — |
Other NDCs under NDA 021845
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 |
|---|---|---|---|---|
| Revatiosildenafil citrate | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-402 |