Prescription drug · ANDA
Sildenafil NDC 0093-5342
Sildenafil citrate 50 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5342-01 | 00093534201 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5342-01)Marketed from Dec 11, 2017 | |
| 0093-5342-56 | 00093534256 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5342-56)Marketed from Dec 11, 2017 |
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)
- Sildenafil
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077342
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-5342_f85e5bfc-be48-4675-8867-1585f412ccb6SPL ID f85e5bfc-be48-4675-8867-1585f412ccb6SPL set ID 5cbac450-f336-45bd-8d10-9ecfd21866ebRxCUI 312950, 314228, 314229UNII 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
N400093534201followed by a unit qualifier and the quantityPackage 00093-5342-01. 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)
Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077342
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 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-267 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1777 |
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5341 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-088 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5343 |