Prescription drug · ANDA
Vardenafil Hydrochloride NDC 62135-864
Vardenafil hydrochloride 2.5 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-864-30 | 62135086430 | 30 TABLET in 1 BOTTLE (62135-864-30)Marketed from Feb 26, 2024 |
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)
- Vardenafil Hydrochloride
- Generic name (nonproprietary)
- vardenafil hydrochloride
- Active ingredients
- Vardenafil hydrochloride — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- 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 62135-864_459d49f5-7be3-8f85-e063-6294a90a2064SPL ID 459d49f5-7be3-8f85-e063-6294a90a2064SPL set ID 57a0c163-a5e8-4c6e-a4ea-114cb2668407RxCUI 402273UNII 5M8S2CU0TSUPC 0362135864309
- 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
N462135086430followed by a unit qualifier and the quantityPackage 62135-0864-30. 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 | 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 | Bryant Ranch Prepack | 71335-9696 |
| 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 |