Prescription drug · ANDA
Vardenafil NDC 70710-1070
Vardenafil hydrochloride trihydrate 10 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1070-1 | 70710107001 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1070-1)Marketed from Nov 1, 2018 | |
| 70710-1070-3 | 70710107003 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1070-3)Marketed from Nov 1, 2018 | |
| 70710-1070-9 | 70710107009 | 90 TABLET, FILM COATED in 1 BOTTLE (70710-1070-9)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
- 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 70710-1070_a6417d62-c65a-49a5-a3c7-d9d178a36cb9SPL ID a6417d62-c65a-49a5-a3c7-d9d178a36cb9SPL set ID 5876e062-e604-42a7-99c3-5da30b8dac06RxCUI 349478, 349479, 349480, 402273UNII 5M8S2CU0TSUPC 0370710106935
- 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
N470710107001followed by a unit qualifier and the quantityPackage 70710-1070-01. 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)
Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ) Vardenafil tablets are indicated for the treatment of erectile dysfunction.
Excerpt only. Read the full label for complete information.
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 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 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1049 |
| 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 |