Prescription drug · ANDA
Sildenafil Citrate (sildenafil) NDC 43063-940
Sildenafil citrate 100 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-940-10 | 43063094010 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-940-10)Marketed from May 16, 2019 | |
| 43063-940-15 | 43063094015 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-940-15)Marketed from Jan 30, 2019 |
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 Citrate
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091448
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 43063-940_52d27749-0bfb-370b-e063-6294a90a1d1cSPL ID 52d27749-0bfb-370b-e063-6294a90a1d1cSPL set ID ace2bb56-4992-49fe-9311-535b12eea9b4RxCUI 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
N443063094010followed by a unit qualifier and the quantityPackage 43063-0940-10. 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)
Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091448
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 Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3111 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3862 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-186 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-187 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-188 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-941 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2241 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4111 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-794 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-231 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3049 |