Prescription drug · ANDA
Vardenafil Hydrochloride NDC 71335-9696
Vardenafil hydrochloride 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9696-1 | 71335969601 | 30 TABLET in 1 BOTTLE (71335-9696-1)Marketed from Apr 12, 2023 |
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 Hydrochloride
- Generic name (nonproprietary)
- vardenafil hydrochloride
- Active ingredients
- Vardenafil hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209057
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-9696_5985fce1-69d7-4821-b750-8b46522cbcbbSPL ID 5985fce1-69d7-4821-b750-8b46522cbcbbSPL set ID 8791997d-3b86-45af-988f-808e259da506RxCUI 349479UNII 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
N471335969601followed by a unit qualifier and the quantityPackage 71335-9696-01. 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 hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209057
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 Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-508 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2236 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2235 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-864 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2800 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9689 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2801 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2802 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2803 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | TabletOral | AvKARE | 42291-826 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | AvKARE | 42291-848 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | TabletOral | AvKARE | 42291-847 |