Prescription drug · ANDA
Vardenafil NDC 70771-1049
Vardenafil hydrochloride trihydrate 10 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1049-1 | 70771104901 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1049-1)Marketed from Nov 1, 2018 | |
| 70771-1049-3 | 70771104903 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1049-3)Marketed from Nov 1, 2018 | |
| 70771-1049-9 | 70771104909 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1049-9)Marketed from Nov 1, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Vardenafil
- Generic name (nonproprietary)
- vardenafil
- Active ingredients
- Vardenafil hydrochloride trihydrate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208960
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1049_4fb9ca6c-4610-42f9-87f0-224d76c542f2SPL ID 4fb9ca6c-4610-42f9-87f0-224d76c542f2SPL set ID 8ea14f7e-44a0-4d9c-968a-87b97ca12f09RxCUI 349478, 349479, 349480, 402273UNII 5M8S2CU0TS
- 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
N470771104901followed by a unit qualifier and the quantityPackage 70771-1049-01. 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 .
Other NDCs under ANDA 208960
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 |
|---|---|---|---|---|
| Vardenafil | Vardenafil hydrochloride trihydrate 20 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1050 |
| Vardenafil | Vardenafil hydrochloride trihydrate 2.5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1068 |
| Vardenafil | Vardenafil hydrochloride trihydrate 5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1069 |
| Vardenafil | Vardenafil hydrochloride trihydrate 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1070 |
| Vardenafil | Vardenafil hydrochloride trihydrate 20 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1071 |
| Vardenafil | Vardenafil hydrochloride trihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-477 |
| Vardenafil | Vardenafil hydrochloride trihydrate 2.5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1047 |
| Vardenafil | Vardenafil hydrochloride trihydrate 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1048 |