Prescription drug · ANDA
Sildenafil NDC 33342-536
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-536-10 | 33342053610 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-536-10)Marketed from Jan 3, 2014 | |
| 33342-536-66 | 33342053666 | 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-536-66)Marketed from Jan 3, 2014 |
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 203814
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-536_d9ad8c65-3264-44dc-b6f9-bdef8467cdadSPL ID d9ad8c65-3264-44dc-b6f9-bdef8467cdadSPL set ID 61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96eRxCUI 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
N433342053610followed by a unit qualifier and the quantityPackage 33342-0536-10. 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 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203814
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 | American Health Packaging | 60687-788 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5115 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-2072 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4517 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-121 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1005 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-597 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-061 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-813 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1638 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-363 |