Prescription drug · ANDA
Vardenafil NDC 33342-203
Vardenafil hydrochloride trihydrate 11.85 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-203-37 | 33342020337 | 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACKMarketed from Oct 26, 2018 |
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
- Generic name (nonproprietary)
- vardenafil
- Active ingredients
- Vardenafil hydrochloride trihydrate — 11.85 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205988
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19SPL ID 695d5a7e-546f-4e86-8edc-3c32e1d3bb19SPL set ID 0ad213e0-d18a-4e67-a405-df95322eaa52RxCUI 996179UNII 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
N433342020337followed by a unit qualifier and the quantityPackage 33342-0203-37. 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 orally disintegrating tablet is indicated for the treatment of erectile dysfunction. Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )
Excerpt only. Read the full label for complete information.
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.