Prescription drug · ANDA
Sildenafil NDC 59746-471
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Jubilant Cadista Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59746-471-05 | 59746047105 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-471-05)Marketed from Aug 26, 2024 | |
| 59746-471-10 | 59746047110 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-471-10)Marketed from Aug 26, 2024 | |
| 59746-471-90 | 59746047190 | 90 TABLET, FILM COATED in 1 BOTTLE (59746-471-90)Marketed from Aug 26, 2024 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202954
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 59746-471_9a1dd479-ab39-4e0e-859b-33c7d7dbbf26SPL ID 9a1dd479-ab39-4e0e-859b-33c7d7dbbf26SPL set ID 7d13bf00-8daf-3087-a0b8-abb1fc572467RxCUI 577033UNII BW9B0ZE037UPC 0359746471057, 0359746471903, 0359746471101
- 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
N459746047105followed by a unit qualifier and the quantityPackage 59746-0471-05. 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 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 that information. Adults Sildenafil tablets are 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 wo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202954
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 | Golden State Medical Supply, Inc. | 51407-987 |